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EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries (ORION)

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ClinicalTrials.gov Identifier: NCT00896337
Recruitment Status : Completed
First Posted : May 11, 2009
Results First Posted : July 3, 2012
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Iliac Artery Stenosis
Interventions Device: Epic™ Nitinol Stent System
Drug: Anti-platelet therapy
Drug: Anti-coagulation therapy
Enrollment 125
Recruitment Details Enrollment of up to 133 subjects was planned; 125 subjects were enrolled at 28 centers in the United States from May 14, 2009 to December 14, 2010.
Pre-assignment Details  
Arm/Group Title ORION
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
Period Title: Overall Study
Started 125
Completed 100
Not Completed 25
Reason Not Completed
Death             7
Withdrawal by Subject             7
Lost to Follow-up             11
Arm/Group Title ORION
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
Overall Number of Baseline Participants 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
<=18 years
0
   0.0%
Between 18 and 65 years
80
  64.0%
>=65 years
45
  36.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants
61.1  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants
Female
44
  35.2%
Male
81
  64.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
Hispanic or Latino 3
Caucasian 112
Black of African heritage 8
American Indian or Alaska Native 1
Asian 0
Other 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 125 participants
125
General Medical History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
Smoking, Ever 121
Medically Treated Diabetes 42
Hyperlipidemia Requiring Medication 98
Hypertension Requiring Medication 95
History of Chronic Obstructive Pulmonary Disease 31
[1]
Measure Description: The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Cardiac History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
History of Coronary Artery Disease 73
History of Myocardial Infarction 36
History of Congestive Heart Failure 10
Stable Angina 15
Unstable Angina 1
Silent Ischemia 0
Previous Percutaneous Coronary Intervention 46
Previous Coronary Artery Bypass Graft 22
[1]
Measure Description: The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Peripheral Vascular History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
History of Peripheral Vascular Surgery 10
History of Other Peripheral Endovascular Intervent 25
History of Claudication 116
[1]
Measure Description: The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Neurologic/Renal History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants
History of Transient Ischemic Attack 5
History of Cerebrovascular Accident 7
History of Renal Insufficiency 9
History of Renal Percutaneous Intervention 6
[1]
Measure Description: The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristic: Target Lesion Vessel   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 125 participants
Left Common Iliac Artery 58
Left External Iliac Artery 16
Right Common Iliac Artery 58
Right External Iliac Artery 28
[1]
Measure Description: These data are reported per lesion. A participant could have more than one lesion, therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristic: Lesion Location   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 125 participants
Ostial 100
Proximal 35
Mid 12
Distal 13
[1]
Measure Description: These data are reported per lesion. A participant could have more than one lesion, therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristics: Size   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 125 participants
Reference Vessel Diameter 7.69  (1.79)
Minimum Lumen Diameter 2.20  (1.34)
Lesion Length 31.04  (22.13)
[1]
Measure Description: These data are reported per lesion.
Lesion Characteristic: Diameter Stenosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 125 participants
71.51  (16.27)
[1]
Measure Description: These data are reported per lesion. A participant could have more than one lesion, therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristics   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 125 participants
Concentric Lesion 72
Eccentric Lesion 88
> 45 Degree Bend 1
> 90 Degree Bend 0
Thrombus 0
Calcification, Non/Mild 37
Calcification, Moderate 45
Calcification, Severe 78
Ulcerated 29
Total Occlusion 26
Aneurysm 10
[1]
Measure Description: These data are reported per lesion. A participant could have more than one lesion; therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group. The same participant’s lesion may also be included in more than one category or not all participants may contribute to a category.
1.Primary Outcome
Title Device- and/or Procedure-related Major Adverse Events (MAE)
Hide Description MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: percentage of participants
3.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Epic Stent
Comments MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of <=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.
Method One-sided exact-test
Comments [Not Specified]
Method of Estimation Estimation Parameter 9-month major adverse event rate
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
0.9 to 8.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Death
Hide Description Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: percentage of participants
0.0
3.Secondary Outcome
Title Death
Hide Description Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: percentage of participants
0.8
4.Secondary Outcome
Title Death
Hide Description Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: percentage of participants
1.8
5.Secondary Outcome
Title Death
Hide Description Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
3.7
6.Secondary Outcome
Title Death
Hide Description Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions
Time Frame 3 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
6.5
7.Secondary Outcome
Title Amputation of Index Limb
Hide Description Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: percentage of participants
0.0
8.Secondary Outcome
Title Amputation of Index Limb
Hide Description Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
0
9.Secondary Outcome
Title Amputation of Index Limb
Hide Description Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
0
10.Secondary Outcome
Title Amputation of Index Limb
Hide Description Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time Frame 3 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
11.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: percentage of participants
2.5
12.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: percentage of participants
3.4
13.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
3.6
14.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
8.5
15.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Time Frame 3 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: percentage of participants
12.9
16.Secondary Outcome
Title Myocardial Infarction (MI)
Hide Description Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.
Time Frame Index hospitalization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: percentage of participants
0.0
17.Secondary Outcome
Title Technical Success
Hide Description Residual lesion stenosis <=30% based on visual assessment immediately postprocedure
Time Frame Index procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epis Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 125
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
166
Measure Type: Number
Unit of Measure: percentage of lesions
100
18.Secondary Outcome
Title Procedure Success
Hide Description Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).
Time Frame In hospital (1-2 days post procedure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: percentage of participants
99.2
19.Secondary Outcome
Title Early Clinical Success
Hide Description

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema

Time Frame Hospital Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of participants
44.2
20.Secondary Outcome
Title Early Clinical Success
Hide Description

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema

Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of participants
87.6
21.Secondary Outcome
Title Late Clinical Success
Hide Description

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema

Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: percentage of patients
89.9
22.Secondary Outcome
Title Late Clinical Success
Hide Description

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema

Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of patients
95.3
23.Secondary Outcome
Title Early Hemodynamic Success
Hide Description Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
Time Frame Hospital Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 113
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
152
Measure Type: Number
Unit of Measure: percentage of limbs
61.2
24.Secondary Outcome
Title Early Hemodynamic Success
Hide Description Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 113
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
151
Measure Type: Number
Unit of Measure: percentage of limbs
66.2
25.Secondary Outcome
Title Late Hemodynamic Success
Hide Description Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 117
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
141
Measure Type: Number
Unit of Measure: percentage of limbs
66.7
26.Secondary Outcome
Title Late Hemodynamic Success
Hide Description Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 114
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
132
Measure Type: Number
Unit of Measure: percentage of limbs
63.6
27.Secondary Outcome
Title Rutherford Classification Distribution
Hide Description

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

  1. = Mild claudication
  2. = Moderate claudication
  3. = Severe claudication
  4. = Ischemic rest pain
  5. = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema
Time Frame Pre-procedure/baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants who received the Epic Stent during the index procedure.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: percentage of participants
Asymptomatic 0.0
Mild Claudication 7.2
Moderate Claudication 33.6
Severe Claudication 54.4
Ischemic Rest Pain 4.8
Minor Tissue Loss 0.0
Major Tissue Loss 0.0
28.Secondary Outcome
Title Rutherford Classification Distribution
Hide Description

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

  1. = Mild claudication
  2. = Moderate claudication
  3. = Severe claudication
  4. = Ischemic rest pain
  5. = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema
Time Frame Post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants who received the Epic Stent during the index procedure.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of participants
Asymptomatic 17.7
Mild Claudication 20.4
Moderate Claudication 35.4
Severe Claudication 23.0
Ischemic Rest Pain 3.5
Minor Tissue Loss 0
Major Tissue Loss 0
29.Secondary Outcome
Title Rutherford Classification Distribution
Hide Description

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

  1. = Mild claudication
  2. = Moderate claudication
  3. = Severe claudication
  4. = Ischemic rest pain
  5. = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants who received the Epic Stent during the index procedure.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of participants
Asymptomatic 65.6
Mild Claudication 16.8
Moderate Claudication 13.3
Severe Claudication 4.4
Ischemic Rest Pain 0
Minor Tissue Loss 0
Major Tissue Loss 0
30.Secondary Outcome
Title Rutherford Classification Distribution
Hide Description

Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss

Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants who received the Epic Stent
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: percentage of participants
Asymptomatic 63.3
Mild Claudication 18.3
Moderate Claudication 15.6
Severe Claudication 2.8
Ischemic Rest Pain 0.0
Minor Tissue Loss 0.0
Major Tissue Loss 0.0
31.Secondary Outcome
Title Rutherford Classification Distribution
Hide Description

Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss

Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants who received the Epic Stent
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
Asymptomatic 76.4
Mild Claudication 12.3
Moderate Claudication 10.4
Severe Claudication 0.9
Ischemic Rest Pain 0
Minor Tissue Loss 0
Major Tissue Loss 0
32.Secondary Outcome
Title Acute Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure.

Time Frame 24 Hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: percentage of participants
0.0
33.Secondary Outcome
Title Sub-acute Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure.

Time Frame >24 Hours to <=30 Days Post-index procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: percentage of participants
2.5
34.Secondary Outcome
Title Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.

Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: percentage of participants
2.5
35.Secondary Outcome
Title Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.

Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
2.7
36.Secondary Outcome
Title Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Very late stent thrombosis is defined as >365 days following the trial procedure.

Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
2.8
37.Secondary Outcome
Title Stent Thrombosis
Hide Description

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Very late stent thrombosis is defined as >365 days following the trial procedure.

Time Frame 3 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: percentage of participants
4.0
38.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 121
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
161
Measure Type: Number
Unit of Measure: percentage of lesions
1.9
39.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 118
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
157
Measure Type: Number
Unit of Measure: percentage of lesions
3.2
40.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 112
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
150
Measure Type: Number
Unit of Measure: percentage of lesions
3.3
41.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Time Frame 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 106
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
143
Measure Type: Number
Unit of Measure: percentage of lesions
5.6
42.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.
Time Frame 3 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 101
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
139
Measure Type: Number
Unit of Measure: percentage of lesions
10.1
43.Secondary Outcome
Title Ankle-Brachial Index (ABI)
Hide Description

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Time Frame Pre-procedure/baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 125
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
159
Mean (Standard Deviation)
Unit of Measure: ratio
0.79  (0.18)
44.Secondary Outcome
Title Ankle-Brachial Index
Hide Description

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Time Frame Hospital Discharge (1-2 days post-procedure)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 125
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
155
Mean (Standard Deviation)
Unit of Measure: ratio
0.96  (0.17)
45.Secondary Outcome
Title Ankle-Brachial Index (ABI)
Hide Description

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 121
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
153
Mean (Standard Deviation)
Unit of Measure: ratio
0.99  (.015)
46.Secondary Outcome
Title Ankle-Brachial Index (ABI)
Hide Description

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 110
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
142
Mean (Standard Deviation)
Unit of Measure: ratio
0.97  (0.17)
47.Secondary Outcome
Title Ankle-Brachial Index (ABI)
Hide Description

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 109
Overall Number of Units Analyzed
Type of Units Analyzed: Limbs
135
Mean (Standard Deviation)
Unit of Measure: ratio
0.96  (0.17)
48.Secondary Outcome
Title Primary Patency
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 95
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
122
Measure Type: Number
Unit of Measure: percentage of lesions
95.9
49.Secondary Outcome
Title Primary Patency
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Measure Type: Number
Unit of Measure: percentage of lesions
93.9
50.Secondary Outcome
Title Primary-assisted Patency (PAP)
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 95
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
122
Measure Type: Number
Unit of Measure: percentage of lesions
98.4
51.Secondary Outcome
Title Primary-assisted Patency (PAP)
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Measure Type: Number
Unit of Measure: percentage of lesions
96.0
52.Secondary Outcome
Title Secondary Patency
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 94
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
120
Measure Type: Number
Unit of Measure: percentage of lesions
100
53.Secondary Outcome
Title Secondary Patency
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
98
Measure Type: Number
Unit of Measure: percentage of lesions
98.0
54.Secondary Outcome
Title Restenosis Assessed by Duplex Ultrasound
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 95
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
122
Measure Type: Number
Unit of Measure: percentage of lesions
2.5
55.Secondary Outcome
Title Restenosis Assessed by Duplex Ultrasound
Hide Description Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
Overall Number of Participants Analyzed 75
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Measure Type: Number
Unit of Measure: percentage of lesions
6.1
56.Secondary Outcome
Title Walking Impairment Questionnaire Score - Distance
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame Pre-procedure/baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.56  (19.36)
57.Secondary Outcome
Title Walking Impairment Questionnaire Score - Distance
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
56.35  (38.97)
58.Secondary Outcome
Title Walking Impairment Questionnaire Score - Distance
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.88  (38.02)
59.Secondary Outcome
Title Walking Impairment Questionnaire Score - Speed
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame Pre-procedure/baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.38  (19.18)
60.Secondary Outcome
Title Walking Impairment Questionnaire Score - Speed
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.45  (31.50)
61.Secondary Outcome
Title Walking Impairment Questionnaire Score - Speed
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 1 Year
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Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.96  (31.80)
62.Secondary Outcome
Title Walking Impairment Questionnaire Score-Stair Climbing
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame Pre-procedure/baseline
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Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.14  (26.91)
63.Secondary Outcome
Title Walking Impairment Questionnaire Score - Stair Climbing
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 9 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.39  (38.08)
64.Secondary Outcome
Title Walking Impairment Questionnaire Score - Stair Climbing
Hide Description The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time Frame 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.
Arm/Group Title Epic Stent
Hide Arm/Group Description:
Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
57.72  (37.17)
Time Frame 3 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ORION
Hide Arm/Group Description All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
All-Cause Mortality
ORION
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ORION
Affected / at Risk (%) # Events
Total   77/125 (61.60%)    
Blood and lymphatic system disorders   
Anaemia  1  1/125 (0.80%)  3
Febrile Neutropenia  1  1/125 (0.80%)  1
Haemorrhagic Anaemia  1  1/125 (0.80%)  1
Pancytopenia  1  1/125 (0.80%)  1
Cardiac disorders   
Acute Coronary Syndrome  1  1/125 (0.80%)  1
Angina Pectoris  1  7/125 (5.60%)  8
Angina Unstable  1  2/125 (1.60%)  2
Atrial Fibrillation  1  7/125 (5.60%)  10
Cardiac Arrest  1  2/125 (1.60%)  2
Coronary Artery Disease  1  4/125 (3.20%)  5
Coronary Artery Stenosis  1  3/125 (2.40%)  3
Ischaemic Cardiomyopathy  1  2/125 (1.60%)  2
Mitral Valve Stenosis  1  1/125 (0.80%)  1
Myocardial Infarction  1  3/125 (2.40%)  3
Acute Myocardial Infarction  1  1/125 (0.80%)  1
Bradycardia  1  1/125 (0.80%)  1
Cardiac Failure Congestive  1  3/125 (2.40%)  3
Sinus Arrhythmia  1  1/125 (0.80%)  1
Eye disorders   
Blindness  1  1/125 (0.80%)  1
Cataract  1  2/125 (1.60%)  3
Gastrointestinal disorders   
Abdominal Pain  1  2/125 (1.60%)  3
Constipation  1  1/125 (0.80%)  2
Gastrointestinal Haemorrhage  1  1/125 (0.80%)  1
Ileus  1  1/125 (0.80%)  1
Upper Gastrointestinal Haemorrhage  1  1/125 (0.80%)  1
Ascites  1  1/125 (0.80%)  1
Colonic Polyp  1  1/125 (0.80%)  1
Large Intestine Perforation  1  1/125 (0.80%)  2
Oesophagitis  1  1/125 (0.80%)  1
Pancreatitis  1  1/125 (0.80%)  1
General disorders   
Catheter Site Haematoma  1  1/125 (0.80%)  1
Catheter Site Haemorrhage  1  1/125 (0.80%)  1
Chest discomfort  1  1/125 (0.80%)  1
Non-cardiac Chest Pain  1  4/125 (3.20%)  5
Oedema Peripheral  1  1/125 (0.80%)  1
Chest Pain  1  1/125 (0.80%)  1
Hepatobiliary disorders   
Bile Duct Stenosis  1  1/125 (0.80%)  1
Cholecystitis Acute  1  1/125 (0.80%)  1
Cholecystitis Chronic  1  1/125 (0.80%)  1
Bile Duct Stone  1  1/125 (0.80%)  1
Cholecystitis  1  1/125 (0.80%)  1
Cholelithiasis  1  1/125 (0.80%)  1
Infections and infestations   
Abdominal Abscess  1  1/125 (0.80%)  1
Clostridial Infection  1  1/125 (0.80%)  1
Diverticulitis  1  1/125 (0.80%)  2
Pneumonia  1  6/125 (4.80%)  7
Wound Infection  1  1/125 (0.80%)  1
Bronchiectasis  1  1/125 (0.80%)  1
Bronchitis  1  1/125 (0.80%)  1
Cellulitis  1  2/125 (1.60%)  2
Septic Shock  1  2/125 (1.60%)  2
Urinary Tract Infection  1  1/125 (0.80%)  1
Injury, poisoning and procedural complications   
Drug Toxicity  1  1/125 (0.80%)  1
Stent-graft Malfunction  1  2/125 (1.60%)  2
Vascular Pseudoaneurysm  1  2/125 (1.60%)  2
Wound Dehiscence  1  1/125 (0.80%)  1
Chemical Eye Injury  1  1/125 (0.80%)  1
Fall  1  1/125 (0.80%)  1
Gun Shot Wound  1  1/125 (0.80%)  1
Post Procedural Haematoma  1  1/125 (0.80%)  1
Procedural Hypotension  1  1/125 (0.80%)  1
Thermal Burn  1  1/125 (0.80%)  1
Investigations   
Blood Creatinine Increased  1  1/125 (0.80%)  1
Metabolism and nutrition disorders   
Hyperkalaemia  1  1/125 (0.80%)  1
Musculoskeletal and connective tissue disorders   
Lumbar Spinal Stenosis  1  2/125 (1.60%)  2
Pain In Extremity  1  1/125 (0.80%)  1
Back Pain  1  1/125 (0.80%)  1
Osteoarthritis  1  1/125 (0.80%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast Cancer  1  1/125 (0.80%)  1
Lung Neoplasm Malignant  1  1/125 (0.80%)  1
Recurrent Cancer  1  1/125 (0.80%)  1
Bladder Cancer  1  1/125 (0.80%)  1
Chronic Lymphocytic Leukaemia  1  1/125 (0.80%)  1
Leukaemia  1  1/125 (0.80%)  1
Lung Carcinoma Cell Type Unspecified Stage IV  1  1/125 (0.80%)  1
Malignant Peritoneal Neoplasm  1  1/125 (0.80%)  1
Metastatic Neoplasm  1  1/125 (0.80%)  1
Prostate Cancer  1  1/125 (0.80%)  1
Nervous system disorders   
Carotid Artery Stenosis  1  4/125 (3.20%)  5
Diplegia  1  1/125 (0.80%)  1
Headache  1  2/125 (1.60%)  2
Hypoaesthesia  1  1/125 (0.80%)  1
Cerebrovascular Accident  1  3/125 (2.40%)  3
Convulsion  1  1/125 (0.80%)  1
Psychiatric disorders   
Mental Status Changes  1  2/125 (1.60%)  2
Depression  1  2/125 (1.60%)  2
Renal and urinary disorders   
Calculus Ureteric  1  1/125 (0.80%)  2
Haematuria  1  1/125 (0.80%)  1
Nephrolithiasis  1  1/125 (0.80%)  1
Renal Artery Stenosis  1  2/125 (1.60%)  2
Renal Failure Acute  1  2/125 (1.60%)  2
Renal Mass  1  1/125 (0.80%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1  1/125 (0.80%)  1
Acute Respiratory Failure  1  2/125 (1.60%)  2
Chronic Obstructive Pulmonary Disease  1  5/125 (4.00%)  8
Pneumonia Aspiration  1  2/125 (1.60%)  2
Dyspnoea  1  3/125 (2.40%)  3
Epistaxis  1  1/125 (0.80%)  1
Pleural Effusion  1  1/125 (0.80%)  1
Pulmonary Oedema  1  1/125 (0.80%)  1
Respiratory Arrest  1  1/125 (0.80%)  1
Vascular disorders   
Angiodysplasia  1  1/125 (0.80%)  1
Arterial Stenosis  1  1/125 (0.80%)  1
Iliac Artery Thrombosis  1  2/125 (1.60%)  2
Intermittent Claudication  1  5/125 (4.00%)  7
Peripheral Artery Dissection  1  3/125 (2.40%)  3
Peripheral Ischaemia  1  1/125 (0.80%)  1
Peripheral Vascular Disorder  1  1/125 (0.80%)  1
Thrombosis  1  1/125 (0.80%)  1
Vascular Occlusion  1  1/125 (0.80%)  1
Vessel Perforation  1  1/125 (0.80%)  1
Aortic Aneurysm  1  2/125 (1.60%)  2
Femoral Arterial Stenosis  1  1/125 (0.80%)  3
Hypertension  1  2/125 (1.60%)  2
Iliac Artery Occlusion  1  1/125 (0.80%)  1
Iliac Artery Stenosis  1  6/125 (4.80%)  6
Leriche Syndrome  1  1/125 (0.80%)  1
Peripheral Arterial Occlusive Disease  1  1/125 (0.80%)  1
Subclavian Steal Syndrome  1  1/125 (0.80%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ORION
Affected / at Risk (%) # Events
Total   63/125 (50.40%)    
Cardiac disorders   
Angina Pectoris  1  7/125 (5.60%)  7
General disorders   
Catheter Site Haematoma  1  10/125 (8.00%)  10
Infections and infestations   
Bronchitis  1  7/125 (5.60%)  8
Musculoskeletal and connective tissue disorders   
Back Pain  1  14/125 (11.20%)  17
Pain In Extremity  1  15/125 (12.00%)  22
Arthralgia  1  10/125 (8.00%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
Results Point of Contact
Name/Title: Angela Schutt
Organization: Boston Scientific
Phone: 763-494-2166
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00896337     History of Changes
Other Study ID Numbers: S2020
First Submitted: May 8, 2009
First Posted: May 11, 2009
Results First Submitted: April 10, 2012
Results First Posted: July 3, 2012
Last Update Posted: May 7, 2015