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ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01468974
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atherosclerosis
Peripheral Vascular Disease
Claudication
Intervention Device: ESPRIT BVS
Enrollment 35
Recruitment Details A total of 35 subjects registered in this study were implanted with the ESPRIT BVS at 7 centers in 4 countries (Belgium, France, Germany and Austria) across Europe. First subject was registered in the ESPRIT I Clinical Investigation on December 20, 2011. The last subject was registered on August 28, 2012.
Pre-assignment Details  
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Period Title: 1 Month Follow-up
Started 35 [1]
Completed 34
Not Completed 1
[1]
Intent-to-treat (ITT) population
Period Title: 6 Months Follow-up
Started 34
Completed 34
Not Completed 0
Period Title: 1 Year Follow-up
Started 34
Completed 34
Not Completed 0
Period Title: 2 Years Follow-up
Started 34
Completed 32
Not Completed 2
Period Title: 3 Years Follow-up
Started 32
Completed 26
Not Completed 6
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
65.3  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
8
  22.9%
Male
27
  77.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
Austria 4
Belgium 20
France 3
Germany 8
1.Primary Outcome
Title Device Success
Hide Description Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Time Frame On Day 0 (From start of index procedure to end of index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of devices
100.0
2.Primary Outcome
Title Technical Success
Hide Description Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.
Time Frame On Day 0 (From start of index procedure to end of index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of target lesions
97.1
3.Primary Outcome
Title Clinical Success
Hide Description

Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated).

*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).

Time Frame > or = 2 days after the index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
97.1
4.Secondary Outcome
Title Number of Participants With Death
Hide Description

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Death
Hide Description

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Death
Hide Description

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Death
Hide Description

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
8.Secondary Outcome
Title Number of Participants With Death
Hide Description

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
9.Secondary Outcome
Title Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Hide Description

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Hide Description

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Hide Description

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Hide Description

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Hide Description

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Hide Description

Amputation:

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
35
 100.0%
15.Secondary Outcome
Title Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Hide Description

Amputation:

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 0 to 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
34
  97.1%
16.Secondary Outcome
Title Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Hide Description

Amputation:

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 0 to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
34
  97.1%
17.Secondary Outcome
Title Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Hide Description

Amputation:

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 0 to 730 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
34
  97.1%
18.Secondary Outcome
Title Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Hide Description

Amputation:

The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.

A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.

Time Frame 0 to 1095 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
30
  85.7%
19.Secondary Outcome
Title Number of Participants With Scaffold Thrombosis
Hide Description Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.
Time Frame 0 to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20.Secondary Outcome
Title Scaffold Occlusion
Hide Description Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Scaffold Occlusion
Hide Description Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
22.Secondary Outcome
Title Number of Participants With Scaffold Occlusion
Hide Description Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.9%
23.Secondary Outcome
Title Number of Participants With Scaffold Occlusion
Hide Description Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
24.Secondary Outcome
Title Number of Participants With Scaffold Occlusion
Hide Description Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Time Frame 0 to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
25.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
27.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
3
   8.8%
28.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
4
  12.1%
29.Secondary Outcome
Title Number of Participants With Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
4
  13.8%
30.Secondary Outcome
Title Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Hide Description A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
31.Secondary Outcome
Title Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Hide Description A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
32.Secondary Outcome
Title Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Hide Description A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.9%
33.Secondary Outcome
Title Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Hide Description A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
34.Secondary Outcome
Title Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Hide Description A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.3%
35.Secondary Outcome
Title Number of Participants With Ipsilateral Extremity Revascularization (IER)
Hide Description

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.

Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
36.Secondary Outcome
Title Number of Participants With Ipsilateral Extremity Revascularization (IER)
Hide Description

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.

Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
37.Secondary Outcome
Title Number of Participants With Ipsilateral Extremity Revascularization (IER)
Hide Description

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.

Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.9%
38.Secondary Outcome
Title Number of Participants With Ipsilateral Extremity Revascularization (IER)
Hide Description

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.

Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
39.Secondary Outcome
Title Number of Participants With Ipsilateral Extremity Revascularization (IER)
Hide Description

Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.

Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.3%
40.Secondary Outcome
Title Number of Participants With Primary Patency
Hide Description At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
41.Secondary Outcome
Title Number of Participants With Primary Patency
Hide Description At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
42.Secondary Outcome
Title Number of Participants With Primary Patency
Hide Description At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
7
  20.6%
43.Secondary Outcome
Title Number of Participants With Primary Patency
Hide Description At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
8
  24.2%
44.Secondary Outcome
Title Number of Participants With Primary Patency
Hide Description At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
9
  31.0%
45.Secondary Outcome
Title Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
Hide Description

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
Category 0
28
  84.8%
Category 1
4
  12.1%
Category 2
1
   3.0%
Category 3
0
   0.0%
Category 4
0
   0.0%
Category 5
0
   0.0%
Category 6
0
   0.0%
46.Secondary Outcome
Title Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
Hide Description

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Category 0
23
  67.6%
Category 1
8
  23.5%
Category 2
3
   8.8%
Category 3
0
   0.0%
Category 4
0
   0.0%
Category 5
0
   0.0%
Category 6
0
   0.0%
47.Secondary Outcome
Title Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
Hide Description

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Category 0
25
  73.5%
Category 1
4
  11.8%
Category 2
3
   8.8%
Category 3
2
   5.9%
Category 4
0
   0.0%
Category 5
0
   0.0%
Category 6
0
   0.0%
48.Secondary Outcome
Title Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
Hide Description

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Category 0
22
  71.0%
Category 1
3
   9.7%
Category 2
4
  12.9%
Category 3
2
   6.5%
Category 4
0
   0.0%
Category 5
0
   0.0%
Category 6
0
   0.0%
49.Secondary Outcome
Title Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
Hide Description

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Category 0
19
  76.0%
Category 1
3
  12.0%
Category 2
3
  12.0%
Category 3
0
   0.0%
Category 4
0
   0.0%
Category 5
0
   0.0%
Category 6
0
   0.0%
50.Secondary Outcome
Title Ankle Brachial Index (ABI) for the Treated Limb
Hide Description

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.

An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

Calculation of the Ankle Brachial Index:

(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: ratio
1.00  (0.11)
51.Secondary Outcome
Title Ankle Brachial Index (ABI) for the Treated Limb
Hide Description

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.

An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

Calculation of the Ankle Brachial Index:

(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: ratio
0.99  (0.13)
52.Secondary Outcome
Title Ankle Brachial Index (ABI) for the Treated Limb
Hide Description

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.

An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

Calculation of the Ankle Brachial Index:

(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: ratio
0.98  (0.15)
53.Secondary Outcome
Title Ankle Brachial Index (ABI) for the Treated Limb
Hide Description

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.

An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

Calculation of the Ankle Brachial Index:

(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: ratio
0.96  (0.16)
54.Secondary Outcome
Title Ankle Brachial Index (ABI) for the Treated Limb
Hide Description

The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.

An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.

Calculation of the Ankle Brachial Index:

(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ratio
0.95  (0.13)
55.Secondary Outcome
Title Walking Impairment Questionnaire (WIQ) Scores
Hide Description

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication.

The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
Walking Distance Score 86.02  (24.58)
Walking Speed Score 56.55  (21.99)
Stair Climbing Score 84.22  (23.93)
56.Secondary Outcome
Title Walking Impairment Questionaire Scores
Hide Description Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
Walking Distance Score 85.81  (24.66)
Walking Speed Score 52.79  (20.27)
Stair Climbing Score 81.25  (25.17)
57.Secondary Outcome
Title Walking Impairment Questionaire Scores
Hide Description Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
Walking Distance Score 84.48  (29.86)
Walking Speed Score 52.69  (22.18)
Stair Climbing Score 87.50  (20.72)
58.Secondary Outcome
Title Walking Impairment Questionaire Scores
Hide Description Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
Walking Distance Score 84.15  (25.70)
Walking Speed Score 50.93  (23.25)
Stair Climbing Score 83.60  (21.86)
59.Secondary Outcome
Title Walking Impairment Questionaire Scores
Hide Description Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
Walking Distance Score 76.11  (25.86)
Walking Speed Score 56.74  (23.35)
Stair Climbing Score 75.50  (22.54)
60.Secondary Outcome
Title In-scaffold Peak Systolic Velocity (PSV)
Hide Description In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: cm/sec
154.6  (46.8)
61.Secondary Outcome
Title In-scaffold Peak Systolic Velocity (PSV)
Hide Description In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: cm/sec
151.5  (37.7)
62.Secondary Outcome
Title In-scaffold Peak Systolic Velocity (PSV)
Hide Description In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: cm/sec
161.5  (72.6)
63.Secondary Outcome
Title In-scaffold Peak Systolic Velocity (PSV)
Hide Description In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: cm/sec
162.7  (47.9)
64.Secondary Outcome
Title In-scaffold Peak Systolic Velocity (PSV)
Hide Description In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: cm/sec
172.5  (67.2)
65.Secondary Outcome
Title In-scaffold Peak Systolic Velocity Ratio (PSVR)
Hide Description In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: ratio
1.26  (0.30)
66.Secondary Outcome
Title In-scaffold Peak Systolic Velocity Ratio (PSVR)
Hide Description Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: ratio
1.35  (0.39)
67.Secondary Outcome
Title In-scaffold Peak Systolic Velocity Ratio (PSVR)
Hide Description Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: ratio
1.66  (1.16)
68.Secondary Outcome
Title In-Scaffold Peak Systolic Velocity Ratio (PSVR)
Hide Description Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ratio
1.56  (0.49)
69.Secondary Outcome
Title In-scaffold Peak Systolic Velocity Ratio (PSVR)
Hide Description Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: ratio
1.66  (0.57)
70.Secondary Outcome
Title Treated Site Percent Diameter Stenosis (%DS)
Hide Description

Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.

  • Reference Vessel Diameter (RVD)
  • Minimum Luminal Diameter(MLD)
Time Frame post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Percent Diameter stenosis
In-Scaffold 9.21  (7.18)
In-Segment 14.01  (8.25)
71.Secondary Outcome
Title Treated Site Percent Diameter Stenosis (%DS)
Hide Description

Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.

  • Reference Vessel Diameter (RVD)
  • Minimum Luminal Diameter(MLD)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Target lesions
28
Mean (Standard Deviation)
Unit of Measure: percent diameter stenosis
In-Scaffold 31.88  (26.06)
In-Segment 35.24  (23.69)
72.Secondary Outcome
Title Treated Site Late Loss
Hide Description

Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up).

The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: Millimeter
In-Scaffold 1.30  (1.53)
In-Segment 1.23  (1.54)
73.Secondary Outcome
Title Binary Restenosis (≥50% DS)
Hide Description

Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA).

Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only

In-scaffold %DS ≥ 50% by Arteriogram Only

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The analysis population included subjects who had available follow up data at that time frame.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of participants
20.6
74.Secondary Outcome
Title Quality of Life Measures: Physical Functioning (PF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
51.26  (7.42)
75.Secondary Outcome
Title Quality of Life Measures: Physical Functioning (PF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.14  (9.00)
76.Secondary Outcome
Title Quality of Life Measures: Physical Functioning (PF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.66  (8.38)
77.Secondary Outcome
Title Quality of Life Measures: Physical Functioning (PF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.49  (10.89)
78.Secondary Outcome
Title Quality of Life Measures: Physical Functioning (PF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.16  (11.09)
79.Secondary Outcome
Title Quality of Life Measures: Role Physical (RP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.64  (9.13)
80.Secondary Outcome
Title Quality of Life Measures: Role Physical (RP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.27  (8.35)
81.Secondary Outcome
Title Quality of Life Measures: Role Physical (RP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.72  (8.41)
82.Secondary Outcome
Title Quality of Life Measures: Role Physical (RP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.37  (11.39)
83.Secondary Outcome
Title Quality of Life Measures: Role Physical (RP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.59  (9.85)
84.Secondary Outcome
Title Quality of Life Measures: Bodily Pain (BP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.34  (10.34)
85.Secondary Outcome
Title Quality of Life Measures: Bodily Pain (BP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.65  (10.66)
86.Secondary Outcome
Title Quality of Life Measures: Bodily Pain (BP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
52.05  (8.78)
87.Secondary Outcome
Title Quality of Life Measures: Bodily Pain (BP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.54  (11.59)
88.Secondary Outcome
Title Quality of Life Measures: Bodily Pain (BP) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
48.88  (10.48)
89.Secondary Outcome
Title Quality of Life Measures: General Health (GH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
48.46  (7.65)
90.Secondary Outcome
Title Quality of Life Measures: General Health (GH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.09  (9.65)
91.Secondary Outcome
Title Quality of Life Measures: General Health (GH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.97  (8.61)
92.Secondary Outcome
Title Quality of Life Measures: General Health (GH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.97  (9.98)
93.Secondary Outcome
Title Quality of Life Measures: General Health (GH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.84  (9.60)
94.Secondary Outcome
Title Quality of Life Measures: Vitality (VT) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.68  (8.99)
95.Secondary Outcome
Title Quality of Life Measures: Vitality (VT) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
56.04  (10.65)
96.Secondary Outcome
Title Quality of Life Measures: Vitality (VT) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
57.81  (10.80)
97.Secondary Outcome
Title Quality of Life Measures: Vitality (VT) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
57.49  (9.89)
98.Secondary Outcome
Title Quality of Life Measures: Vitality (VT) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.72  (11.86)
99.Secondary Outcome
Title Quality of Life Measures: Social Functioning (SF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.51  (4.71)
100.Secondary Outcome
Title Quality of Life Measures: Social Functioning (SF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.33  (9.95)
101.Secondary Outcome
Title Quality of Life Measures: Social Functioning (SF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
52.71  (8.62)
102.Secondary Outcome
Title Quality of Life Measures: Social Functioning (SF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.05  (12.10)
103.Secondary Outcome
Title Quality of Life Measures: Social Functioning (SF) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.11  (8.69)
104.Secondary Outcome
Title Quality of Life Measures: Role Emotional (RE) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.98  (9.42)
105.Secondary Outcome
Title Quality of Life Measures: Role Emotional (RE) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
51.31  (9.25)
106.Secondary Outcome
Title Quality of Life Measures: Role Emotional (RE) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
50.98  (10.70)
107.Secondary Outcome
Title Quality of Life Measures: Role Emotional (RE) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
49.04  (11.99)
108.Secondary Outcome
Title Quality of Life Measures: Role Emotional (RE) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.24  (13.24)
109.Secondary Outcome
Title Quality of Life Measures: Mental Health (MH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
57.52  (7.94)
110.Secondary Outcome
Title Quality of Life Measures: Mental Health (MH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.76  (9.98)
111.Secondary Outcome
Title Quality of Life Measures: Mental Health (MH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
58.09  (10.39)
112.Secondary Outcome
Title Quality of Life Measures: Mental Health (MH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.10  (10.54)
113.Secondary Outcome
Title Quality of Life Measures: Mental Health (MH) Summary
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.37  (11.60)
114.Secondary Outcome
Title Quality of Life Measures: Physical Component Summary (PCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
48.61  (8.78)
115.Secondary Outcome
Title Quality of Life Measures: Physical Component Summary (PCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
47.54  (9.53)
116.Secondary Outcome
Title Quality of Life Measures: Physical Component Summary (PCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
48.56  (8.03)
117.Secondary Outcome
Title Quality of Life Measures: Physical Component Summary (PCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.27  (11.13)
118.Secondary Outcome
Title Quality of Life Measures: Mental Component Summary (MCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.67  (7.27)
119.Secondary Outcome
Title Quality of Life Measures: Physical Component Summary (PCS)
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The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
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ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
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Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
46.80  (11.00)
120.Secondary Outcome
Title Quality of Life Measures: Mental Component Summary (MCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
55.12  (10.32)
121.Secondary Outcome
Title Quality of Life Measures: Mental Component Summary (MCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
56.64  (11.33)
122.Secondary Outcome
Title Quality of Life Measures: Mental Component Summary (MCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
54.97  (11.44)
123.Secondary Outcome
Title Quality of Life Measures: Mental Component Summary (MCS)
Hide Description

The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
52.58  (11.69)
124.Secondary Outcome
Title Vascular Quality of Life (VascuQol) Scores Summary
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Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.

The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.

Time Frame At 1 month
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Hide Analysis Population Description
ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
Activity Domain 6.02  (0.90)
Symptom Domain 6.36  (0.60)
Pain Domain 6.26  (1.05)
Emotional Domain 6.35  (0.87)
Social Domain 6.44  (0.79)
125.Secondary Outcome
Title Vascular Quality of Life (VascuQol) Scores Summary
Hide Description

Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.

The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.

Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
Activity Domain 5.68  (0.98)
Symptom Domain 6.15  (0.91)
Pain Domain 6.20  (1.14)
Emotional Domain 6.31  (0.90)
Social Domain 6.40  (1.13)
126.Secondary Outcome
Title Vascular Quality of Life (VascuQol) Scores Summary
Hide Description

Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.

The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.

Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.
Arm/Group Title ESPRIT BVS
Hide Arm/Group Description:
Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
Activity Domain 5.76  (0.83)
Symptom Domain 6.34  (0.91)
Pain Domain 6.21  (1.17)
Emotional Domain 6.44  (0.97)
Social Domain 6.68  (0.81)
127.Secondary Outcome
Title Vascular Quality of Life (VascuQol) Scores Summary