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Trial record 1 of 2 for:    NCT01319812
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Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents (BIOFLEX-I)

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: NCT01319812
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : June 5, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peripheral Artery Disease
Peripheral Vascular Disease
Interventions Device: Astron Stents
Device: Pulsar Stents
Enrollment 463
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description Subjects implanted with an Astron stent. Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
Period Title: Overall Study
Started 161 302
Completed 145 280
Not Completed 16 22
Arm/Group Title Astron Stent Group Pulsar Stent Group Total
Hide Arm/Group Description Subjects implanted with an Astron stent. Subjects implanted with an Astron Pulsar or Pulsar-18 stent. Total of all reporting groups
Overall Number of Baseline Participants 161 302 463
Hide Baseline Analysis Population Description
The two arms of the BIOFLEX-I study were distinct with no overlap. Totals present here were automatically generated by the clinicaltrials.gov system. Four participants were enrolled in both the Astron and Pulsar stent groups, as allowed in the study protocol. Therefore any presented totals may not be accurate aggregates of data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 302 participants 463 participants
63.6  (10.1) 67.3  (10.3) NA [1]   (NA)
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Female
56
  34.8%
97
  32.1%
153
  33.0%
Male
105
  65.2%
205
  67.9%
310
  67.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Hispanic or Latino
18
  11.2%
21
   7.0%
39
   8.4%
Not Hispanic or Latino
143
  88.8%
281
  93.0%
424
  91.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.2%
Asian
4
   2.5%
7
   2.3%
11
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   2.5%
22
   7.3%
26
   5.6%
White
152
  94.4%
273
  90.4%
425
  91.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
United States 91 187 NA [1] 
Canada 38 29 NA [1] 
Austria 32 34 NA [1] 
Belgium 0 32 NA [1] 
Switzerland 0 6 NA [1] 
Germany 0 14 NA [1] 
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Diabetes 32 123 NA [1] 
Hypertension 117 255 NA [1] 
Hyperlipidemia 125 245 NA [1] 
Current smoker 78 122 NA [1] 
Smoked within last 5 years 36 46 NA [1] 
Never smoked or not within last 5 years 47 134 NA [1] 
Cerebrovascular disease 22 48 NA [1] 
History of congestive heart failure 11 27 NA [1] 
History of ischemic heart disease 69 124 NA [1] 
History of coronary revasularization 54 110 NA [1] 
Renal insufficiency 11 17 NA [1] 
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Lesion Location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Common iliac 107 0 107
External iliac 54 0 54
Ostial SFA 0 2 2
Proximal SFA 0 38 38
Mid SFA 0 156 156
Distal SFA 0 99 99
Proximal popliteal 0 7 7
Lesion Calcification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
None 47 82 NA [1] 
Moderate 68 91 NA [1] 
Severe 46 129 NA [1] 
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Lesion Length  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 161 participants 302 participants 463 participants
35.9  (21.3) 82.0  (46.9) NA [1]   (NA)
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Vessel Diameter  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 161 participants 302 participants 463 participants
Pre-deployment Minimum Lumen Diameter (MLD) 2.1  (1.3) 1.0  (0.9) NA [1]   (NA)
Post-deployment Minimum Lumen Diameter (MLD) 6.0  (1.2) 4.1  (0.7) NA [1]   (NA)
Reference vessel diameter 7.6  (1.5) 5.0  (0.9) NA [1]   (NA)
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Distal Vessel Runoff  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Not Available 35 32 NA [1] 
0 Vessel 9 19 NA [1] 
1 Vessel 32 74 NA [1] 
2 Vessel 48 93 NA [1] 
3 Vessel 37 84 NA [1] 
[1]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
Trans-Atlantic Inter-Society Consensus (TASC II) Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 302 participants 463 participants
Type A 99 166 NA [2] 
Type B 56 106 NA [2] 
Type C 6 26 NA [2] 
Type D 0 3 NA [2] 
[1]
Measure Description: TASC II grading is from the Trans-Atlantic Inter-Society Consensus. Type A lesions include a single stenosis <10 cm long or a single occlusion <5cm long; type B lesions include multiple lesions <5 cm, a single lesion <15cm, or a single popliteal stenosis; type C lesions include multiple stenosis or occlusions >15 cm with or without calcification, or a chronic total occlusion >20cm involving the popliteal; type D lesions include chronic total occlusions of the popliteal artery and proximal vessels. Generally, Type D lesions are mores severe than Type A lesions.
[2]
Study arms are independent with no overlap or comparison. A total would not present meaningful information and would be conflated by four subjects who were enrolled in both arms of the study.
1.Primary Outcome
Title Effectiveness Endpoint for the Pulsar Stent: Primary Patency
Hide Description The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for whom patency could be confirmed at 12 months.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
66.8
(60.8 to 72.4)
2.Primary Outcome
Title Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
Hide Description The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants implanted with an Astron Pulsar or Pulsar-18 stent.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 302
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.7
(98.2 to 100.0)
3.Primary Outcome
Title Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
Hide Description The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.
Arm/Group Title Astron Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Overall Number of Participants Analyzed 146
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.1
(0.4 to 5.9)
4.Primary Outcome
Title Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
Hide Description Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.2
(72.7 to 83.1)
5.Secondary Outcome
Title Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation
Hide Description Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants implanted with an Astron Pulsar or Pulsar-18 stent.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 302
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Freedom from 30 day mortality
99.7
(98.2 to 100.0)
Freedom from 30 day TLR
100.0
(98.8 to 100.0)
Freedom from 30 day index limb amputation
100.0
(98.8 to 100.0)
6.Secondary Outcome
Title Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate
Hide Description Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who reached at least 395 calendar days post procedure.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30-day mortality
0.4
(0.0 to 2.0)
Target lesion revascularization
12.4
(8.8 to 16.8)
Index limb amputation
0.4
(0.0 to 2.0)
7.Secondary Outcome
Title Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate
Hide Description Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 243
Measure Type: Count of Participants
Unit of Measure: Participants
Overall stent fracture at 12 months
14
   5.8%
Grade I stent fracture at 12 months
4
   1.6%
Grade II stent fracture at 12 months
3
   1.2%
Grade III stent fracture at 12 months
3
   1.2%
Grade IV stent fracture at 12 months
4
   1.6%
Grade V stent fracture at 12 months
0
   0.0%
8.Secondary Outcome
Title Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate
Hide Description Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.
Arm/Group Title Astron Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Overall Number of Participants Analyzed 146
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30-day mortality
0.7
(0.0 to 3.8)
Target Lesion Revascularization
1.4
(0.2 to 4.5)
Index limb amputation
0.0
(0.0 to 2.5)
9.Secondary Outcome
Title Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate
Hide Description Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.
Arm/Group Title Astron Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Overall Number of Participants Analyzed 128
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
89.8
(83.3 to 94.5)
10.Secondary Outcome
Title Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency
Hide Description Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 146 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.9
(94.1 to 99.6)
98.9
(96.8 to 99.8)
11.Secondary Outcome
Title Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency
Hide Description Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 146 276
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.3
(96.2 to 100.0)
98.2
(95.8 to 99.4)
12.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement
Hide Description The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 141 266
Mean (Standard Deviation)
Unit of Measure: Ratio (ABI score)
Baseline ABI 0.71  (0.15) 0.70  (0.14)
12-Month Visit ABI 0.94  (0.18) 0.91  (0.19)
ABI difference 0.23  (0.19) 0.22  (0.21)
13.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test
Hide Description The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 131 247
Mean (Standard Deviation)
Unit of Measure: Feet
Six-minute walk distance at baseline 868.9  (446.5) 875.3  (379.1)
Six-minute walk distance at 12-month visit 1026.4  (469.5) 1088.9  (468.9)
Six-minute walk distance difference 157.5  (420.6) 213.6  (412.7)
14.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score
Hide Description

The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:

Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 143 265
Mean (Standard Deviation)
Unit of Measure: Units on a scale (WIQ score)
WIQ PAD Specific Score at Baseline 36.2  (29.0) 36.7  (28.1)
WIQ PAD Specific Score at 12-Month Visit 80.1  (29.2) 75.8  (32.3)
WIQ PAD Specific Score Difference 43.9  (36.8) 39.1  (40.4)
15.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score
Hide Description

The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:

Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 144 264
Mean (Standard Deviation)
Unit of Measure: Units on a scale (WIQ score)
WIQ Walking Dist Score at Baseline 21.3  (24.2) 26.1  (26.3)
WIQ Walking Dist Score at 12-Month Visit 62.0  (39.5) 58.7  (38.9)
WIQ Walking Dist Score Difference 40.7  (38.0) 32.6  (37.4)
16.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score
Hide Description

The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:

Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 143 263
Mean (Standard Deviation)
Unit of Measure: Units on a scale (WIQ score)
WIQ Walking Speed Score at Baseline 22.3  (19.2) 25.2  (21.2)
WIQ Walking Speed Score at 12-Month Visit 43.8  (28.6) 43.5  (28.0)
WIQ Walking Speed Score Difference 21.5  (27.5) 18.3  (28.1)
17.Secondary Outcome
Title Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score
Hide Description

The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:

Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 142 255
Mean (Standard Deviation)
Unit of Measure: Units on a scale (WIQ score)
WIQ Stair Climbing Score at Baseline 30.0  (27.1) 36.8  (31.5)
WIQ Stair Climbing Score at 12-Month Visit 56.1  (36.8) 56.9  (37.8)
WIQ Stair Climbing Score Difference 26.1  (35.6) 20.1  (36.0)
18.Secondary Outcome
Title Acute Procedural Success for Astron and Pulsar Stent
Hide Description Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent implantation.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 161 302
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.0
(90.4 to 97.8)
98.0
(95.7 to 99.3)
19.Secondary Outcome
Title Clinical Success
Hide Description Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.
Time Frame 30 days
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Hide Analysis Population Description
The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 161 301
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.0
(90.4 to 97.8)
97.7
(95.3 to 99.1)
20.Secondary Outcome
Title Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates
Hide Description Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent implantation.
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 161 302
Measure Type: Number
Unit of Measure: Participants with event
Serious adverse events 67 180
Non-serious adverse events 94 277
21.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate
Hide Description Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 12 134 91 211
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 2.2 0.0 0.5
22.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months
Hide Description Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 10 118 82 186
Measure Type: Number
Unit of Measure: Percentage of participants
80.0 90.7 59.8 69.9
23.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months
Hide Description Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 12 134 83 192
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 97.8 96.4 100.0
24.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months
Hide Description Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 12 134 84 192
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 99.3 97.6 98.4
25.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success
Hide Description Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame Acute / Date of Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent implantation.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 13 148 91 211
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 94.6 97.8 98.1
26.Secondary Outcome
Title Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success
Hide Description Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent implantation.
Arm/Group Title Astron Stent Group - Occlusive Lesion Astron Stent Group - Non-occlusive Pulsar Stent Group - Occlusive Lesion Pulsar Stent Group - Non-occlusive Lesion
Hide Arm/Group Description:
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Overall Number of Participants Analyzed 13 148 90 211
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 94.6 97.8 97.6
27.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate
Hide Description Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 247 36
Measure Type: Number
Unit of Measure: Percentage of participants
10.9 25.0
28.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months
Hide Description Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 235 33
Measure Type: Number
Unit of Measure: Percentage of participants
68.5 54.5
29.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months
Hide Description Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 213 30
Measure Type: Number
Unit of Measure: Percentage of participants
4.7 13.3
30.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months
Hide Description Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 241 34
Measure Type: Number
Unit of Measure: Percentage of participants
99.2 97.1
31.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months
Hide Description Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 239 34
Measure Type: Number
Unit of Measure: Percentage of participants
98.8 94.1
32.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success
Hide Description Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame Acute / Date of Procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 265 37
Measure Type: Number
Unit of Measure: Percentage of participants
98.1 97.3
33.Secondary Outcome
Title Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success
Hide Description Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
Arm/Group Title Pulsar Stent Group - Standard Lesion Length Pulsar Stent Group - Long Lesion Length
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
Overall Number of Participants Analyzed 265 36
Measure Type: Number
Unit of Measure: Percentage of participants
97.7 97.2
34.Secondary Outcome
Title Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)
Hide Description Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent.
Time Frame 24 Months
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Hide Analysis Population Description
Evaluable participants for TLR at 24 months.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 268
Measure Type: Count of Participants
Unit of Measure: Participants
217
  81.0%
35.Secondary Outcome
Title Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)
Hide Description Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants at 24 months.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 269
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MAE - Related to stent or index procedure
19.3
(14.8 to 24.6)
30-day mortality
0.4
(0.0 to 2.1)
Clinically-driven TLR
19.0
(14.5 to 24.2)
Index limb amputation
0.8
(.01 to 2.7)
36.Secondary Outcome
Title Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).
Hide Description Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants at 36 months.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 258
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MAE - Related to stent or index procedure
22.1
(17.2 to 27.7)
- 30-day mortality
0.4
(0.0 to 2.1)
- Clinically-driven TLR
21.8
(16.9 to 27.3)
- Index limb amputation
1.2
(0.2 to 3.4)
37.Secondary Outcome
Title Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)
Hide Description [Not Specified]
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants for TLR at 24 months.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 268
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
20.9
(16.2 to 26.3)
38.Secondary Outcome
Title Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)
Hide Description [Not Specified]
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants for TLR at 36 months. Pulsar Stent Group Post Market Analysis.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 257
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.7
(18.7 to 29.4)
39.Secondary Outcome
Title Number of Participants With Stent Fracture at 24 Months (Post Approval).
Hide Description [Not Specified]
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants for stent fracture at 24 months. Pulsar Stent Group Post Market Analysis.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 230
Measure Type: Count of Participants
Unit of Measure: Participants
10
   4.3%
40.Secondary Outcome
Title Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).
Hide Description [Not Specified]
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants for stent fracture at 36 months. Pulsar Stent Group Post Market Analysis.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 204
Measure Type: Count of Participants
Unit of Measure: Participants
13
   6.4%
41.Secondary Outcome
Title Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).
Hide Description Summary of serious adverse event rates at 36 months. Refer to SAE section.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Pulsar Stent Group Post Market Analysis.
Arm/Group Title Pulsar Stent Group
Hide Arm/Group Description:
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Overall Number of Participants Analyzed 302
Measure Type: Count of Participants
Unit of Measure: Participants
230
  76.2%
Time Frame Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events.
Adverse Event Reporting Description For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
 
Arm/Group Title Astron Stent Group Pulsar Stent Group
Hide Arm/Group Description Subjects indicated for stenting in iliac atherosclerotic lesions. Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
All-Cause Mortality
Astron Stent Group Pulsar Stent Group
Affected / at Risk (%) Affected / at Risk (%)
Total   5/161 (3.11%)      27/302 (8.94%)    
Hide Serious Adverse Events
Astron Stent Group Pulsar Stent Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/161 (41.61%)      180/302 (59.60%)    
Blood and lymphatic system disorders     
Abnormal coagulation profile   0/161 (0.00%)  0 1/302 (0.33%)  1
Anemia   1/161 (0.62%)  1 12/302 (3.97%)  15
Bleeding requiring treatment   2/161 (1.24%)  2 1/302 (0.33%)  1
Epistaxis   0/161 (0.00%)  0 1/302 (0.33%)  1
Leukocytosis   1/161 (0.62%)  1 4/302 (1.32%)  4
Thrombocytopenia   0/161 (0.00%)  0 2/302 (0.66%)  2
Cardiac disorders     
Abdominal aortic aneurysm   0/161 (0.00%)  0 2/302 (0.66%)  2
Angina   1/161 (0.62%)  1 8/302 (2.65%)  9
Atrial arrhythmia   2/161 (1.24%)  2 9/302 (2.98%)  10
Bradycardia   0/161 (0.00%)  0 3/302 (0.99%)  3
Cardiac arrest   1/161 (0.62%)  1 9/302 (2.98%)  9
Cardiac catheterization   2/161 (1.24%)  2 0/302 (0.00%)  0
Cardiogenic shock   0/161 (0.00%)  0 1/302 (0.33%)  1
Chest pain   1/161 (0.62%)  1 11/302 (3.64%)  12
Coronary artery disease   4/161 (2.48%)  4 26/302 (8.61%)  27
Dilated cardiomyopathy   0/161 (0.00%)  0 1/302 (0.33%)  1
Dizziness   1/161 (0.62%)  1 2/302 (0.66%)  2
Dyspnea   0/161 (0.00%)  0 6/302 (1.99%)  6
Edema   0/161 (0.00%)  0 4/302 (1.32%)  4
Elevated troponin   0/161 (0.00%)  0 1/302 (0.33%)  1
Fatigue   0/161 (0.00%)  0 1/302 (0.33%)  1
Fluctuating blood pressure   0/161 (0.00%)  0 1/302 (0.33%)  1
Heart block   0/161 (0.00%)  0 1/302 (0.33%)  1
Hypertension   0/161 (0.00%)  0 7/302 (2.32%)  8
Hypertensive crisis   0/161 (0.00%)  0 1/302 (0.33%)  1
Hypotension   0/161 (0.00%)  0 9/302 (2.98%)  12
Ischemic cardiomyopathy   0/161 (0.00%)  0 3/302 (0.99%)  3
Medication reaction/toxicity   0/161 (0.00%)  0 1/302 (0.33%)  1
Myocardial infarction   1/161 (0.62%)  1 14/302 (4.64%)  16
Palpitations   0/161 (0.00%)  0 1/302 (0.33%)  1
Patent foramen ovale closure   0/161 (0.00%)  0 1/302 (0.33%)  1
Pericarditis   1/161 (0.62%)  1 1/302 (0.33%)  1
Superior mesenteric artery stenosis   1/161 (0.62%)  1 0/302 (0.00%)  0
Syncope   0/161 (0.00%)  0 7/302 (2.32%)  8
Tachycardia   0/161 (0.00%)  0 1/302 (0.33%)  1
Valvular heart disease   0/161 (0.00%)  0 5/302 (1.66%)  5
Ventricular arrhythmia   1/161 (0.62%)  1 1/302 (0.33%)  1
Worsening cardiomyopathy   0/161 (0.00%)  0 1/302 (0.33%)  1
Worsening coronary artery disease   0/161 (0.00%)  0 1/302 (0.33%)  1
Worsening heart failure   1/161 (0.62%)  1 18/302 (5.96%)  24
Endocrine disorders     
Diabetic ketoacidosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Hyperglycemia   1/161 (0.62%)  1 6/302 (1.99%)  7
Hyperlipidemia   0/161 (0.00%)  0 1/302 (0.33%)  1
Hypoglycemia   0/161 (0.00%)  0 6/302 (1.99%)  6
Worsening diabetic control   0/161 (0.00%)  0 4/302 (1.32%)  4
Eye disorders     
Bleeding left eye   1/161 (0.62%)  1 0/302 (0.00%)  0
Cataract   1/161 (0.62%)  1 6/302 (1.99%)  6
Horner's syndrome, right eye   0/161 (0.00%)  0 1/302 (0.33%)  1
Neovascular glaucoma   0/161 (0.00%)  0 1/302 (0.33%)  1
Gastrointestinal disorders     
Abdominal pain   3/161 (1.86%)  4 5/302 (1.66%)  6
Bariatric surgery   0/161 (0.00%)  0 1/302 (0.33%)  1
Bleeding   5/161 (3.11%)  5 10/302 (3.31%)  17
Colitis   0/161 (0.00%)  0 1/302 (0.33%)  1
Colon/rectal polyp(s)   0/161 (0.00%)  0 1/302 (0.33%)  1
Colonoscopy   0/161 (0.00%)  0 1/302 (0.33%)  1
Constipation   0/161 (0.00%)  0 2/302 (0.66%)  2
Crohn's disease   0/161 (0.00%)  0 1/302 (0.33%)  1
Diarrhea   1/161 (0.62%)  1 0/302 (0.00%)  0
Diverticulitis   0/161 (0.00%)  0 5/302 (1.66%)  6
Gallstone   0/161 (0.00%)  0 1/302 (0.33%)  1
Gastric bypass surgery   0/161 (0.00%)  0 2/302 (0.66%)  2
Gastric ulcer(s)   0/161 (0.00%)  0 1/302 (0.33%)  1
Gastritis   0/161 (0.00%)  0 3/302 (0.99%)  3
Hernia   0/161 (0.00%)  0 1/302 (0.33%)  1
Hernia, hiatal   0/161 (0.00%)  0 1/302 (0.33%)  1
Hernia, inguinal   0/161 (0.00%)  0 2/302 (0.66%)  2
Ischemic colitis/colon polyps   0/161 (0.00%)  0 1/302 (0.33%)  1
Nausea and/or vomiting   1/161 (0.62%)  1 6/302 (1.99%)  6
Suspected abdominal ischemia   0/161 (0.00%)  0 1/302 (0.33%)  1
Ventral and umbilical hernia   0/161 (0.00%)  0 1/302 (0.33%)  1
General disorders     
Death-cause undetermined   0/161 (0.00%)  0 1/302 (0.33%)  1
Dehydration   0/161 (0.00%)  0 4/302 (1.32%)  5
Fever   0/161 (0.00%)  0 1/302 (0.33%)  1
Headache   0/161 (0.00%)  0 1/302 (0.33%)  1
Non-cardiac chest pain   0/161 (0.00%)  0 4/302 (1.32%)  4
Open or non-healing wound/ulcer   0/161 (0.00%)  0 2/302 (0.66%)  2
Open wounds due to injury   0/161 (0.00%)  0 1/302 (0.33%)  1
Syncope   0/161 (0.00%)  0 2/302 (0.66%)  2
Traumatic injury   1/161 (0.62%)  1 6/302 (1.99%)  6
Weakness   0/161 (0.00%)  0 2/302 (0.66%)  2
Infections and infestations     
Bacterial infection   0/161 (0.00%)  0 1/302 (0.33%)  1
Breast   0/161 (0.00%)  0 1/302 (0.33%)  1
Bronchitis   0/161 (0.00%)  0 5/302 (1.66%)  5
Cellulitis   0/161 (0.00%)  0 6/302 (1.99%)  7
Clostridium difficile   0/161 (0.00%)  0 2/302 (0.66%)  2
E. coli infection   1/161 (0.62%)  1 0/302 (0.00%)  0
Erysipelas   1/161 (0.62%)  1 2/302 (0.66%)  2
Fungemia   0/161 (0.00%)  0 1/302 (0.33%)  1
Gastroenteritis   0/161 (0.00%)  0 2/302 (0.66%)  2
Groin wound   0/161 (0.00%)  0 1/302 (0.33%)  1
Infection resulting in amputation   0/161 (0.00%)  0 1/302 (0.33%)  1
Ingrown toenail   0/161 (0.00%)  0 1/302 (0.33%)  1
Inner ear infection   0/161 (0.00%)  0 1/302 (0.33%)  1
MRSA   0/161 (0.00%)  0 1/302 (0.33%)  1
Osteomyelitis resulting in amputation   0/161 (0.00%)  0 1/302 (0.33%)  1
Perirectal abscess   0/161 (0.00%)  0 1/302 (0.33%)  1
Pneumonia   2/161 (1.24%)  2 17/302 (5.63%)  17
Pocket infection   0/161 (0.00%)  0 1/302 (0.33%)  1
Positive E. faecalis   1/161 (0.62%)  1 0/302 (0.00%)  0
Sepsis   0/161 (0.00%)  0 2/302 (0.66%)  2
Septic shock   0/161 (0.00%)  0 5/302 (1.66%)  6
Septic shock resulting in amputation   0/161 (0.00%)  0 2/302 (0.66%)  2
Sinusitis   0/161 (0.00%)  0 1/302 (0.33%)  1
Surgical site - elbow   0/161 (0.00%)  0 1/302 (0.33%)  1
Thrush   0/161 (0.00%)  0 1/302 (0.33%)  1
Toenail fungus   0/161 (0.00%)  0 1/302 (0.33%)  1
Tonsillitis   0/161 (0.00%)  0 1/302 (0.33%)  1
Tuberculosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Urinary tract infection   1/161 (0.62%)  1 8/302 (2.65%)  8
Urosepsis   0/161 (0.00%)  0 1/302 (0.33%)  1
Wound drainage/Purulant drainage   1/161 (0.62%)  1 1/302 (0.33%)  1
Wound infection   0/161 (0.00%)  0 2/302 (0.66%)  2
Injury, poisoning and procedural complications     
Allergic reaction to contrast media or anti-thrombotic meds   1/161 (0.62%)  1 2/302 (0.66%)  2
Anaphylactic shock   0/161 (0.00%)  1/302 (0.33%)  1
Metabolism and nutrition disorders     
Electrolyte imbalance   2/161 (1.24%)  2 6/302 (1.99%)  6
Malnutrition   0/161 (0.00%)  0 1/302 (0.33%)  1
Musculoskeletal and connective tissue disorders     
Back surgery   0/161 (0.00%)  0 1/302 (0.33%)  1
Bursitis   0/161 (0.00%)  0 2/302 (0.66%)  2
Chronic shoulder dislocation   0/161 (0.00%)  0 1/302 (0.33%)  1
Fall   0/161 (0.00%)  0 1/302 (0.33%)  1
Fracture   1/161 (0.62%)  1 10/302 (3.31%)  11
Gonathrosis of the knee   0/161 (0.00%)  0 1/302 (0.33%)  1
Herniated disc   0/161 (0.00%)  0 1/302 (0.33%)  1
Lumbar laminectomy and fusion   1/161 (0.62%)  1 0/302 (0.00%)  0
Musculoskeletal injury   1/161 (0.62%)  1 7/302 (2.32%)  7
Musculoskeletal pain   2/161 (1.24%)  2 14/302 (4.64%)  16
Osteoarthritis   0/161 (0.00%)  0 2/302 (0.66%)  2
Osteonecrosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Osteoporosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer   6/161 (3.73%)  6 19/302 (6.29%)  21
Vocal cord polyps   0/161 (0.00%)  0 1/302 (0.33%)  1
Nervous system disorders     
Axonal sensible polyneuropathy   1/161 (0.62%)  1 0/302 (0.00%)  0
Carpal tunnel syndrome   0/161 (0.00%)  0 1/302 (0.33%)  1
Myoclonus   0/161 (0.00%)  0 1/302 (0.33%)  1
Seizure   0/161 (0.00%)  0 1/302 (0.33%)  2
Stroke   1/161 (0.62%)  1 8/302 (2.65%)  9
Tinnitus   0/161 (0.00%)  0 1/302 (0.33%)  1
Transient ischemic attack   2/161 (1.24%)  2 3/302 (0.99%)  3
Vasovagal episode   0/161 (0.00%)  0 1/302 (0.33%)  1
Vertigo   0/161 (0.00%)  0 1/302 (0.33%)  1
Psychiatric disorders     
Altered mental status   1/161 (0.62%)  1 5/302 (1.66%)  5
Depression   0/161 (0.00%)  0 2/302 (0.66%)  2
Renal and urinary disorders     
Acute kidney injury   0/161 (0.00%)  0 2/302 (0.66%)  2
Acute pyelonephritis   1/161 (0.62%)  1 0/302 (0.00%)  0
Acute renal failure   0/161 (0.00%)  0 1/302 (0.33%)  1
Cystocele   0/161 (0.00%)  0 1/302 (0.33%)  1
Hematuria   0/161 (0.00%)  0 1/302 (0.33%)  1
Increased serum creatinine   0/161 (0.00%)  0 3/302 (0.99%)  3
Kidney stone(s)   0/161 (0.00%)  0 5/302 (1.66%)  5
Muliple organ failure   0/161 (0.00%)  0 1/302 (0.33%)  1
Renal failure   1/161 (0.62%)  1 6/302 (1.99%)  8
Ureter obstruction   0/161 (0.00%)  0 1/302 (0.33%)  1
Urinary retention   0/161 (0.00%)  0 2/302 (0.66%)  2
Worsening renal function   0/161 (0.00%)  0 9/302 (2.98%)  9
Reproductive system and breast disorders     
Benign prostatic hyperplasia   0/161 (0.00%)  0 2/302 (0.66%)  2
Hernia vaginal   0/161 (0.00%)  0 1/302 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   0/161 (0.00%)  0 1/302 (0.33%)  2
Asthma   1/161 (0.62%)  1 1/302 (0.33%)  2
Chronic obstructive pulmonary disease   2/161 (1.24%)  5 6/302 (1.99%)  6
Dyspnea   1/161 (0.62%)  1 4/302 (1.32%)  4
Hemoptysis   1/161 (0.62%)  1 0/302 (0.00%)  0
Pleural effusions   0/161 (0.00%)  0 1/302 (0.33%)  1
Profound hypoxia   0/161 (0.00%)  0 1/302 (0.33%)  1
Pulmonary edema   0/161 (0.00%)  0 1/302 (0.33%)  1
Pulmonary embolism   0/161 (0.00%)  0 1/302 (0.33%)  1
Respiratory arrest   0/161 (0.00%)  0 3/302 (0.99%)  3
Respiratory compromise   0/161 (0.00%)  0 1/302 (0.33%)  1
Sleep apnea   0/161 (0.00%)  0 1/302 (0.33%)  1
Sudden respiratory distress   0/161 (0.00%)  0 1/302 (0.33%)  1
Skin and subcutaneous tissue disorders     
Psoriasis   0/161 (0.00%)  0 1/302 (0.33%)  1
Skin condition/rash   0/161 (0.00%)  0 2/302 (0.66%)  2
Surgical and medical procedures     
Angioplasty on left external iliac and SFA   1/161 (0.62%)  1 0/302 (0.00%)  0
Failure to deliver stent to intended site   1/161 (0.62%)  1 1/302 (0.33%)  1
Hematoma   0/161 (0.00%)  0 5/302 (1.66%)  5
ICD/pacemaker device replacement   1/161 (0.62%)  1 2/302 (0.66%)  2
Nausea and/or vomiting   0/161 (0.00%)  0 1/302 (0.33%)  1
Planned carotid stenting   0/161 (0.00%)  0 1/302 (0.33%)  1
Planned PVI in contralateral extremity   0/161 (0.00%)  0 10/302 (3.31%)  10
Post-surgical wound discomfort   0/161 (0.00%)  0 1/302 (0.33%)  1
Pseudoaneurysm - procedure related   0/161 (0.00%)  0 3/302 (0.99%)  3
Thrombosis or occlusion during stenting procedure   0/161 (0.00%)  0 1/302 (0.33%)  1
Vessel dissection or perforation during placement of thrombolysis catheter   0/161 (0.00%)  0 1/302 (0.33%)  1
Vessel dissection or perforation during PTA/ prior to stenting   1/161 (0.62%)  1 8/302 (2.65%)  8
Vessel dissection or perforation during stenting procedure   1/161 (0.62%)  1 4/302 (1.32%)  4
Vascular disorders     
Acute mesenteric ischemia   0/161 (0.00%)  0 1/302 (0.33%)  1
Arterial embolization distal to puncture site   0/161 (0.00%)  0 1/302 (0.33%)  1
Basilar artery stenosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Carotid artery disease   0/161 (0.00%)  0 1/302 (0.33%)  1
Carotid stenosis   0/161 (0.00%)  0 11/302 (3.64%)  13
Compartment syndrome   0/161 (0.00%)  0 1/302 (0.33%)  1
Contralateral iliac dissection   0/161 (0.00%)  0 2/302 (0.66%)  2
Deep vein thrombosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Discoloration of 5th right toe   0/161 (0.00%)  0 1/302 (0.33%)  1
Gangrene resulting in amputation   0/161 (0.00%)  0 2/302 (0.66%)  2
Hematoma - non-index procedure related   0/161 (0.00%)  0 7/302 (2.32%)  7
Numbness and/or tingling in lower extremities   0/161 (0.00%)  0 1/302 (0.33%)  1
Occlusion of bypass graft left illiopopliteal bypass conduit   1/161 (0.62%)  1 0/302 (0.00%)  0
Open or non-healing wound/ulcer   0/161 (0.00%)  0 7/302 (2.32%)  8
Peripheral ischemia   3/161 (1.86%)  4 3/302 (0.99%)  3
Phlegmon of the forefoot - led to amputation   0/161 (0.00%)  0 1/302 (0.33%)  1
Pseudoaneurysm   3/161 (1.86%)  3 3/302 (0.99%)  3
Pseudoaneurysm - non-index procedure related   0/161 (0.00%)  0 2/302 (0.66%)  2
Renal artery stenosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Right femoral occlusion   2/161 (1.24%)  2 0/302 (0.00%)  0
Stenosis or occlusion in contralateral extremity   14/161 (8.70%)  15 66/302 (21.85%)  83
Stenosis or occlusion in target extremity outside of stent segment   8/161 (4.97%)  9 50/302 (16.56%)  69
Stenosis or occlusion of target lesion within stent segment   2/161 (1.24%)  2 61/302 (20.20%)  84
Subclavian stenosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Thrombosis in target lesion stenosis/ occlusion   0/161 (0.00%)  0 6/302 (1.99%)  7
Thrombosis of a non-target vessel, contralateral   0/161 (0.00%)  0 1/302 (0.33%)  1
Thrombotic occlusion of a bypass graft   0/161 (0.00%)  0 2/302 (0.66%)  2
Varicose veins   0/161 (0.00%)  0 2/302 (0.66%)  2
Venous insufficiency   0/161 (0.00%)  0 1/302 (0.33%)  1
Venous thrombosis   0/161 (0.00%)  0 1/302 (0.33%)  1
Worsening claudication   0/161 (0.00%)  0 2/302 (0.66%)  2
Worsening of claudication   1/161 (0.62%)  1 2/302 (0.66%)  2
Worsening of PAD   0/161 (0.00%)  0 1/302 (0.33%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Astron Stent Group Pulsar Stent Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/161 (20.50%)      179/302 (59.27%)    
Blood and lymphatic system disorders     
Anemia   0/161 (0.00%)  0 16/302 (5.30%)  17
Cardiac disorders     
Chest pain   8/161 (4.97%)  11 24/302 (7.95%)  26
Dizziness/ lightheadedness   8/161 (4.97%)  8 17/302 (5.63%)  20
Dyspnea   0/161 (0.00%)  0 23/302 (7.62%)  26
Edema   0/161 (0.00%)  0 33/302 (10.93%)  38
Hypertension   0/161 (0.00%)  0 22/302 (7.28%)  25
Musculoskeletal and connective tissue disorders     
Leg pain and/or cramping   0/161 (0.00%)  0 16/302 (5.30%)  17
Musculoskeletal pain   23/161 (14.29%)  24 67/302 (22.19%)  96
Numbness and/or tingling in lower extremities   0/161 (0.00%)  0 16/302 (5.30%)  17
Renal and urinary disorders     
Urinary tract infection   0/161 (0.00%)  0 19/302 (6.29%)  23
Skin and subcutaneous tissue disorders     
Skin condition/rash   0/161 (0.00%)  0 16/302 (5.30%)  20
Surgical and medical procedures     
Hematoma - Non-index procedure related   0/161 (0.00%)  0 24/302 (7.95%)  27
Vascular disorders     
Stenosis or occlusion in contralateral extremity   0/161 (0.00%)  0 39/302 (12.91%)  46
Stenosis or occlusion in target exremity outside of stent segment   0/161 (0.00%)  0 23/302 (7.62%)  27
Stenosis or occlusion of target lesion within stent segment   0/161 (0.00%)  0 39/302 (12.91%)  46
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amy Culley, Director of Vascular Intervention
Organization: BIOTRONIK
Phone: 503-451-8034
EMail: amy.culley@biotronik.com
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01319812    
Other Study ID Numbers: BIOFLEX-I
First Submitted: March 18, 2011
First Posted: March 22, 2011
Results First Submitted: September 2, 2016
Results First Posted: June 5, 2017
Last Update Posted: March 21, 2019