Trial Outcomes & Findings for Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery (NCT NCT00933270)

NCT ID: NCT00933270

Last Updated: 2017-05-30

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

325 participants

Primary outcome timeframe

30 days

Results posted on

2017-05-30

Participant Flow

A total of 46 sites in the US enrolled 325 subjects into this study. The first patient was enrolled on July 30, 2009 and the last patient was enrolled on May 20, 2011. Intention-To-Treat (ITT) population included 264 subjects and Per-Protocol (PP) population included 257 subjects. In addition, 61 roll-in subjects were enrolled.

Participant milestones

Participant milestones
Measure	Supera® Peripheral Stent System Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Overall Study STARTED	264
Overall Study COMPLETED	177
Overall Study NOT COMPLETED	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Supera® Peripheral Stent System Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Overall Study Withdrawal by Subject	26
Overall Study Insufficient Follow-up	10
Overall Study Lost to Follow-up	14
Overall Study Adverse Event	1
Overall Study Missed Visit	2
Overall Study Death	24
Overall Study Moved or would not return	10

Baseline Characteristics

Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Age, Continuous ITT population	68.7 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	244 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants
Race (NIH/OMB) White	221 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	264 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Per ITT set. Patients are included in the clinical endpoint if: * They return for their visit within the window * They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame * The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=260 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days. Freedom from Death,TLR or amputation (30 days)	99.2 percentage of participants Interval 97.2 to 99.9
Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days. Freedom from All Cause Death to 30 days	99.6 percentage of participants Interval 97.9 to 100.0
Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days. Freedom from TLR to 30 days	99.6 percentage of participants Interval 97.9 to 100.0
Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days. Freedom from Amputation of the index limb(30 days)	100.0 percentage of participants Interval 98.6 to 100.0

PRIMARY outcome

Timeframe: 12 months

Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=228 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR. Patency rate at 12 months	78.9 percentage of participants Interval 73.1 to 84.1
Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR. No restenosis at 12 months	86.7 percentage of participants Interval 81.6 to 90.9
Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR. Freedom from TLR at 12 months	88.9 percentage of participants Interval 84.2 to 92.6

SECONDARY outcome

Timeframe: intraoperative

Population: Per ITT set: Post-procedure angiogram analyzed by core lab

Technical (lesion) success, defined as the attainment of \<50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=262 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Technical (Lesion) Success	100.0 percentage of treated segments Interval 98.6 to 100.0

SECONDARY outcome

Timeframe: intraoperative

Population: Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay

Defined as device success with \< 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=261 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Procedural Success	100.0 percentage of participants Interval 98.6 to 100.0

SECONDARY outcome

Timeframe: intraoperative

Population: Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab

Device success, defined as achievement of a final residual diameter stenosis of \<50% (by QA), using the assigned treatment only.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=261 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Device Success	98.5 percentage of participants Interval 96.1 to 99.6

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=233 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Secondary Safety Composite Endpoint	12.45 percentage of participants Interval 8.5 to 17.38

SECONDARY outcome

Timeframe: 24 months (± 30 Days)

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=213 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Secondary Safety Endpoint	19.25 percentage of participants Interval 14.18 to 25.19

SECONDARY outcome

Timeframe: 36 months (± 30 Days)

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=178 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Secondary Safety Endpoint	24.16 percentage of participants Interval 18.07 to 31.13

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=235 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)	11.5 percentage of participants Interval 7.7 to 16.3

SECONDARY outcome

Timeframe: 24 months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=215 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)	17.7 percentage of participants Interval 12.8 to 23.4

SECONDARY outcome

Timeframe: 36 months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=184 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)	22.3 percentage of participants Interval 16.5 to 29.0

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V. Stent fracture classification * Type I - a single strut fracture only. * Type II - multiple single nitinol stent fractures that can occur at different sites. * Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement. * Type IV - a complete transverse linear type III fracture with stent displacement. * Type V - a spiral dissection of a stent.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=244 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Stent Fracture Rate Single Strut	0 percentage of participants
Stent Fracture Rate Multiple Strut	0 percentage of participants
Stent Fracture Rate Fragments Aligned	0 percentage of participants
Stent Fracture Rate Fragments Malaligned	0 percentage of participants
Stent Fracture Rate Spiral Fracture	0 percentage of participants

SECONDARY outcome

Timeframe: 24 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=202 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Stent Fracture Rate Single Strut	0 percentage of participants
Stent Fracture Rate Multiple Strut	0 percentage of participants
Stent Fracture Rate Fragments Aligned	0.5 percentage of participants
Stent Fracture Rate Fragments Malaligned	0 percentage of participants
Stent Fracture Rate Spiral Fracture	0 percentage of participants

SECONDARY outcome

Timeframe: 36 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=162 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Stent Fracture Rate Single Strut	0 percentage of participants
Stent Fracture Rate Multiple Strut	0 percentage of participants
Stent Fracture Rate Fragments Aligned	0.6 percentage of participants
Stent Fracture Rate Fragments Malaligned	0 percentage of participants
Stent Fracture Rate Spiral Fracture	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set: Baseline ABI measured prior to study procedure

A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=257 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Ankle-brachial Index (ABI) Measurements on Target Limb	0.73 ratio Standard Deviation 0.18

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=251 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Ankle-brachial Index (ABI) Measurements on Target Limb	0.99 ratio Standard Deviation 0.17

SECONDARY outcome

Timeframe: 6 Months (± 14 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=226 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Ankle-brachial Index (ABI) on Target Limb	0.92 ratio Standard Deviation 0.22

SECONDARY outcome

Timeframe: 12 Months (± 30 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=227 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Ankle-brachial Index (ABI) on Target Limb	0.92 ratio Standard Deviation 0.22

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=241 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Lesion Revascularization (TLR)	1.7 percentage of participants Interval 0.5 to 4.2

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=235 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Lesion Revascularization (TLR)	11.1 percentage of participants Interval 7.4 to 15.8

SECONDARY outcome

Timeframe: 24 months (± 30 Days)

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=215 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Lesion Revascularization (TLR)	16.7 percentage of participants Interval 12.0 to 22.4

SECONDARY outcome

Timeframe: 36 months (± 30 Days)

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=183 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Lesion Revascularization (TLR)	21.3 percentage of participants Interval 15.6 to 28.0

SECONDARY outcome

Timeframe: 6 Months (± 14 days)

Population: Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit \& sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed \& analyzed by core lab

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=225 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
SFA Patency: PSV Ratio ≥ 2.0	84.9 percentage of participants Interval 79.5 to 89.3

SECONDARY outcome

Timeframe: 6 Months (± 14 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=225 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
SFA Patency: PSV Ratio > 2.4	86.2 percentage of participants Interval 81.0 to 90.4

SECONDARY outcome

Timeframe: 12 Months (±30 days)

Population: Per ITT set. Patients are included if they return for visit within the window, returned for a later visit \& sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed \& analyzed by core lab

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=228 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
SFA Patency: PSV Ratio > 2.4	80.3 percentage of participants Interval 74.5 to 85.2

SECONDARY outcome

Timeframe: 6 months (± 14 days)

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=241 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Vessel Revascularization	2.5 percentage of participants Interval 0.9 to 5.3

SECONDARY outcome

Timeframe: 12 months (±30 days)

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=235 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Vessel Revascularization	13.2 percentage of participants Interval 9.1 to 18.2

SECONDARY outcome

Timeframe: 24 months (±30 days)

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=215 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Vessel Revascularization	20.5 percentage of participants Interval 15.3 to 26.5

SECONDARY outcome

Timeframe: 36 months (±30 days)

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=186 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Target Vessel Revascularization	25.8 percentage of participants Interval 19.7 to 32.7

SECONDARY outcome

Timeframe: 1 month (± 7 days)

Population: Per ITT set. Patients are included in the Limb ischemia improvement if: They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done.

Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one. Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to \>0.90. Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized. Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both). Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10. Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation. Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=259 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Limb Ischemia Improvement: Rutherford Becker Scale	97.3 percentage of limbs

SECONDARY outcome

Timeframe: 12 Months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Limb Ischemia Improvement: Rutherford Becker Scale	89.1 percentage of limbs

SECONDARY outcome

Timeframe: 24 Months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=203 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Limb Ischemia Improvement: Rutherford Becker Scale	89.2 percentage of limbs

SECONDARY outcome

Timeframe: 36 Months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=167 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Limb Ischemia Improvement: Rutherford Becker Scale	92.2 percentage of limbs

SECONDARY outcome

Timeframe: 30 days (±7 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=260 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Major Adverse Events (MAVE) Stent Thrombosis	0.4 percentage of participants
Major Adverse Events (MAVE) Clinically Apparent Distal Embolization	0.4 percentage of participants
Major Adverse Events (MAVE) Procedure-Related Arterial Rupture	0 percentage of participants
Major Adverse Events (MAVE) Acute Limb Ischemia	0.4 percentage of participants
Major Adverse Events (MAVE) Target Limb Amputation	0 percentage of participants
Major Adverse Events (MAVE) Procedure Related Bleeding Requiring Transfusion	0.4 percentage of participants

SECONDARY outcome

Timeframe: 6 Months (±14 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=241 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Major Adverse Events (MAVE) Stent Thrombosis	0.4 percentage of participants
Major Adverse Events (MAVE) Clinically Apparent Distal Embolization	0.4 percentage of participants
Major Adverse Events (MAVE) Procedure-Related Arterial Rupture	0 percentage of participants
Major Adverse Events (MAVE) Acute Limb Ischemia	0.8 percentage of participants
Major Adverse Events (MAVE) Target Limb Amputation	0 percentage of participants
Major Adverse Events (MAVE) Procedure Related Bleeding Requiring Transfusion	1.2 percentage of participants

SECONDARY outcome

Timeframe: 12 months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=235 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Major Adverse Events (MAVE) Stent Thrombosis	0.9 percentage of participants
Major Adverse Events (MAVE) Clinically Apparent Distal Embolization	0.9 percentage of participants
Major Adverse Events (MAVE) Procedure-Related Arterial Rupture	0 percentage of participants
Major Adverse Events (MAVE) Acute Limb Ischemia	1.7 percentage of participants
Major Adverse Events (MAVE) Target Limb Amputation	0.4 percentage of participants
Major Adverse Events (MAVE) Procedure Related Bleeding Requiring Transfusion	1.3 percentage of participants

SECONDARY outcome

Timeframe: 24 months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=209 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Major Adverse Events (MAVE) Stent Thrombosis	1.4 percentage of participants
Major Adverse Events (MAVE) Clinically Apparent Distal Embolization	1.0 percentage of participants
Major Adverse Events (MAVE) Procedure-Related Arterial Rupture	0 percentage of participants
Major Adverse Events (MAVE) Acute Limb Ischemia	1.9 percentage of participants
Major Adverse Events (MAVE) Target Limb Amputation	1.0 percentage of participants
Major Adverse Events (MAVE) Procedure Related Bleeding Requiring Transfusion	1.4 percentage of participants

SECONDARY outcome

Timeframe: 36 months (±30 days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=175 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Major Adverse Events (MAVE) Stent Thrombosis	1.7 percentage of participants
Major Adverse Events (MAVE) Clinically Apparent Distal Embolization	1.1 percentage of participants
Major Adverse Events (MAVE) Procedure-Related Arterial Rupture	0 percentage of participants
Major Adverse Events (MAVE) Acute Limb Ischemia	2.3 percentage of participants
Major Adverse Events (MAVE) Target Limb Amputation	1.1 percentage of participants
Major Adverse Events (MAVE) Procedure Related Bleeding Requiring Transfusion	1.7 percentage of participants

SECONDARY outcome

Timeframe: 6 months (±14 days)

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=240 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Index Limb Amputations	0 percentage of participants Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: 12 months (±30 days)

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=233 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Index Limb Amputations	0.4 percentage of participants Interval 0.0 to 2.4

SECONDARY outcome

Timeframe: 24 months (±30 days)

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=207 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Index Limb Amputations	1.0 percentage of participants Interval 0.1 to 3.4

SECONDARY outcome

Timeframe: 36 months (±30 days)

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=173 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Index Limb Amputations	1.2 percentage of participants Interval 0.1 to 4.1

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the SF-12 Questionnaire prior to the study procedure

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed (QoL) by SF-12 Questionnaire Physical Summary Scale	31.83 units on a scale Standard Deviation 10.11
Quality of Life Assessed (QoL) by SF-12 Questionnaire Mental Summary Scale	49.25 units on a scale Standard Deviation 11.86

SECONDARY outcome

Timeframe: 6 Months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the SF-12 Questionnaire at the visit.

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=233 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by SF-12 Questionnaire Physical Summary Scale	38.90 units on a scale Standard Deviation 11.59
Quality of Life Assessed by SF-12 Questionnaire Mental Summary Scale	51.51 units on a scale Standard Deviation 11.06

SECONDARY outcome

Timeframe: 12 Months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the SF-12 Questionnaire at the visit

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=229 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by SF-12 Questionnaire Physical Summary Scale	39.62 units on a scale Standard Deviation 11.03
Quality of Life Assessed by SF-12 Questionnaire Mental Summary Scale	51.20 units on a scale Standard Deviation 10.37

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=256 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	26.16 units on a scale Standard Deviation 23.06

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=209 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	52.85 units on a scale Standard Deviation 31.72

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=206 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	56.47 units on a scale Standard Deviation 28.82

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	37.10 units on a scale Standard Deviation 24.40

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=231 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	69.99 units on a scale Standard Deviation 29.25

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	72.00 units on a scale Standard Deviation 27.71

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	39.02 units on a scale Standard Deviation 21.53

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=232 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	55.17 units on a scale Standard Deviation 23.38

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=229 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	52.62 units on a scale Standard Deviation 20.65

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=261 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	48.02 units on a scale Standard Deviation 28.13

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=211 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	73.16 units on a scale Standard Deviation 29.30

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=211 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	76.01 units on a scale Standard Deviation 25.60

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	86.46 units on a scale Standard Deviation 18.77

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=232 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	87.41 units on a scale Standard Deviation 19.22

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	88.48 units on a scale Standard Deviation 18.07

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	35.23 units on a scale Standard Deviation 23.87

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=232 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	68.70 units on a scale Standard Deviation 29.15

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	70.27 units on a scale Standard Deviation 27.00

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the PAQ Questionnaire prior to the study procedure

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	36.91 units on a scale Standard Deviation 20.94

SECONDARY outcome

Timeframe: 6 months (± 14 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=232 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	66.89 units on a scale Standard Deviation 25.95

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Population: Per ITT set. Patients are included in the QoL endpoint if: They completed the follow-up visit and the PAQ Questionnaire at the visit

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	69.09 units on a scale Standard Deviation 23.19

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.

Category and Clinical Description 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=264 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Category: Rutherford Becker Asymptomatic	0 percentage of limbs
Clinical Category: Rutherford Becker Mild Claudication	0 percentage of limbs
Clinical Category: Rutherford Becker Moderate Claudication	37.5 percentage of limbs
Clinical Category: Rutherford Becker Severe Claudication	57.2 percentage of limbs
Clinical Category: Rutherford Becker Ischemic Rest Pain	5.3 percentage of limbs
Clinical Category: Rutherford Becker Minor Tissue Loss	0 percentage of limbs
Clinical Category: Rutherford Becker Major Tissue Loss	0 percentage of limbs

SECONDARY outcome

Timeframe: 1 Month (± 7 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=259 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Category: Rutherford Becker Asymptomatic	69.9 percentage of limbs
Clinical Category: Rutherford Becker Mild Claudication	23.9 percentage of limbs
Clinical Category: Rutherford Becker Moderate Claudication	5.0 percentage of limbs
Clinical Category: Rutherford Becker Severe Claudication	1.2 percentage of limbs
Clinical Category: Rutherford Becker Ischemic Rest Pain	0 percentage of limbs
Clinical Category: Rutherford Becker Minor Tissue Loss	0 percentage of limbs
Clinical Category: Rutherford Becker Major Tissue Loss	0 percentage of limbs

SECONDARY outcome

Timeframe: 12 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Category: Rutherford Becker Asymptomatic	64.3 percentage of limbs
Clinical Category: Rutherford Becker Mild Claudication	18.7 percentage of limbs
Clinical Category: Rutherford Becker Moderate Claudication	13.9 percentage of limbs
Clinical Category: Rutherford Becker Severe Claudication	2.2 percentage of limbs
Clinical Category: Rutherford Becker Ischemic Rest Pain	0 percentage of limbs
Clinical Category: Rutherford Becker Minor Tissue Loss	0.9 percentage of limbs
Clinical Category: Rutherford Becker Major Tissue Loss	0 percentage of limbs

SECONDARY outcome

Timeframe: 24 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=203 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Category: Rutherford Becker Mild Claudication	17.7 percentage of limbs
Clinical Category: Rutherford Becker Moderate Claudication	10.3 percentage of limbs
Clinical Category: Rutherford Becker Severe Claudication	2.0 percentage of limbs
Clinical Category: Rutherford Becker Ischemic Rest Pain	0 percentage of limbs
Clinical Category: Rutherford Becker Minor Tissue Loss	2.0 percentage of limbs
Clinical Category: Rutherford Becker Major Tissue Loss	0 percentage of limbs
Clinical Category: Rutherford Becker Asymptomatic	68.0 percentage of limbs

SECONDARY outcome

Timeframe: 36 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=169 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Category: Rutherford Becker Asymptomatic	72.2 percentage of limbs
Clinical Category: Rutherford Becker Mild Claudication	16.0 percentage of limbs
Clinical Category: Rutherford Becker Moderate Claudication	8.3 percentage of limbs
Clinical Category: Rutherford Becker Severe Claudication	2.4 percentage of limbs
Clinical Category: Rutherford Becker Ischemic Rest Pain	0 percentage of limbs
Clinical Category: Rutherford Becker Minor Tissue Loss	1.2 percentage of limbs
Clinical Category: Rutherford Becker Major Tissue Loss	0 percentage of limbs

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.

Clinical Improvement Compared With Baseline Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=259 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +3 Markedly Improved	68.0 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +2 Moderately Improved	23.2 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +1 Minimally Improved	6.2 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade 0 No Change	2.7 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -1 Mildly Worse	0 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -2 Moderately Worsening	0 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -3 Markedly Worsening	0 percentage of limbs

SECONDARY outcome

Timeframe: 12 Months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=230 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -1 Mildly Worse	1.3 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -2 Moderately Worsening	0.9 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -3 Markedly Worsening	0.4 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +3 Markedly Improved	53.5 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +2 Moderately Improved	24.3 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +1 Minimally Improved	11.3 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade 0 No Change	8.3 percentage of limbs

SECONDARY outcome

Timeframe: 24 Months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=203 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +3 Markedly Improved	56.7 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +2 Moderately Improved	25.1 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +1 Minimally Improved	7.4 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade 0 No Change	4.4 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -1 Mildly Worse	1.5 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -2 Moderately Worsening	3.4 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -3 Markedly Worsening	1.5 percentage of limbs

SECONDARY outcome

Timeframe: 36 Months (± 30 Days)

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=167 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +3 Markedly Improved	65.9 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +2 Moderately Improved	19.8 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade +1 Minimally Improved	6.6 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade 0 No Change	6.0 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -1 Mildly Worse	0.6 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -2 Moderately Worsening	0.0 percentage of limbs
Clinical Improvement Compared With Baseline: Rutherford Becker Scale Grade -3 Markedly Worsening	1.2 percentage of limbs

SECONDARY outcome

Timeframe: Baseline

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=21 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Distance	82.32 meters Standard Deviation 62.09

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=17 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Distance	158.87 meters Standard Deviation 140.07

SECONDARY outcome

Timeframe: 12 months

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=19 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Distance	158.53 meters Standard Deviation 134.95

SECONDARY outcome

Timeframe: Baseline

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=23 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Time (CPT)	117.59 seconds Standard Deviation 88.41

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=17 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Time (CPT)	188.12 seconds Standard Deviation 151.58

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=19 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Claudication Pain Time (CPT)	195.58 seconds Standard Deviation 158.57

SECONDARY outcome

Timeframe: Baseline

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=23 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Distance	195.38 meters Standard Deviation 107.67

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=18 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Distance	294.18 meters Standard Deviation 244.24

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=19 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Distance	262.61 meters Standard Deviation 141.58

SECONDARY outcome

Timeframe: Baseline

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=23 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Time	245.71 seconds Standard Deviation 136.00

SECONDARY outcome

Timeframe: 1 month (± 7 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=18 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Time	345.22 seconds Standard Deviation 255.76

SECONDARY outcome

Timeframe: 12 months (± 30 Days)

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Outcome measures

Outcome measures
Measure	Supera® Peripheral Stent System n=19 Participants Implantation of Supera stent using the Supera® Peripheral Stent System Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent
Exercise Tolerance Test: Maximal Walking Time	317.53 seconds Standard Deviation 159.38

Adverse Events

Supera® Peripheral Stent System ITT

Serious events: 151 serious events

Other events: 211 other events

Deaths: 0 deaths

Supera® Peripheral Stent System Roll-in

Serious events: 36 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Supera® Peripheral Stent System ITT n=264 participants at risk Implantation of Supera stent using the Supera® Peripheral Stent System. ITT population consisted of 264 subjects.	Supera® Peripheral Stent System Roll-in n=61 participants at risk Implantation of Supera stent using the Supera® Peripheral Stent System. There were a total of 61 roll-in subjects.
Blood and lymphatic system disorders Anaemia	3.4% 9/264 • Number of events 9 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Blood and lymphatic system disorders Haemorrhagic anaemia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Blood and lymphatic system disorders Iron deficiency anaemia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Acute coronary syndrome	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Acute myocardial infarction	3.8% 10/264 • Number of events 10 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Angina pectoris	1.1% 3/264 • Number of events 4 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Angina unstable	2.7% 7/264 • Number of events 9 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Cardiac disorders Arrhythmia	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Atrial fibrillation	1.1% 3/264 • Number of events 3 • 3 Years	6.6% 4/61 • Number of events 4 • 3 Years
Cardiac disorders Atrial flutter	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Atrioventricular block first degree	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Atrioventricular block second degree	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Bradycardia	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Cardiac arrest	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Cardiac failure	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Cardiac failure acute	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Cardiac failure chronic	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Cardiac failure congestive	3.4% 9/264 • Number of events 14 • 3 Years	3.3% 2/61 • Number of events 4 • 3 Years
Cardiac disorders Cardiogenic shock	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Coronary artery disease	6.4% 17/264 • Number of events 22 • 3 Years	3.3% 2/61 • Number of events 3 • 3 Years
Cardiac disorders Coronary artery occlusion	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders In-stent coronary artery restenosis	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Ischaemic cardiomyopathy	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Left ventricular dysfunction	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Myocardial infarction	1.1% 3/264 • Number of events 5 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Palpitations	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Sick sinus syndrome	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Supraventricular tachycardia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Tachycardia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Ventricular extrasystoles	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Cardiac disorders Ventricular tachycardia	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Congenital, familial and genetic disorders Spondylolisthesis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Ear and labyrinth disorders Vertigo	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Gastrointestinal disorders Abdominal pain	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Abdominal pain upper	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Gastrointestinal disorders Colitis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Constipation	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Diarrhoea	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Dysphagia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Gastritis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Gastrointestinal haemorrhage	3.0% 8/264 • Number of events 8 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Ileus	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Intestinal ischaemia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Intra-abdominal haematoma	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Nausea	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Reflux gastritis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Retroperitoneal haematoma	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Retroperitoneal haemorrhage	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Small intestinal obstruction	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
General disorders Brain death	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Cardiac death	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Catheter site haematoma	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Chest discomfort	0.00% 0/264 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
General disorders Chest pain	5.7% 15/264 • Number of events 18 • 3 Years	4.9% 3/61 • Number of events 3 • 3 Years
General disorders Death	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
General disorders Multi-organ failure	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
General disorders Necrosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Non-cardiac chest pain	0.76% 2/264 • Number of events 2 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
General disorders Oedema peripheral	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Pain	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Hepatobiliary disorders Cholecystitis	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Hepatobiliary disorders Cholecystitis acute	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Immune system disorders Iodine allergy	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Abscess	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Infections and infestations Bacterial sepsis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Bronchitis	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Catheter site infection	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Cellulitis	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 2 • 3 Years
Infections and infestations Diverticulitis	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Gangrene	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Gastroenteritis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Gastroenteritis viral	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Infections and infestations Meningitis viral	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Osteomyelitis	1.9% 5/264 • Number of events 8 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Infections and infestations Pneumonia	3.8% 10/264 • Number of events 11 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Infections and infestations Pneumonia staphylococcal	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Sepsis	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Septic shock	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Staphylococcal sepsis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Urinary tract infection	1.1% 3/264 • Number of events 3 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Injury, poisoning and procedural complications Device malfunction	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Fall	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 2 • 3 Years
Injury, poisoning and procedural complications Femur fracture	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Head injury	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Hip fracture	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications In-stent arterial restenosis	6.4% 17/264 • Number of events 24 • 3 Years	4.9% 3/61 • Number of events 4 • 3 Years
Injury, poisoning and procedural complications Medical device complication	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Open wound	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Post procedural swelling	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Pubic rami fracture	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Renal injury	1.5% 4/264 • Number of events 4 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Seroma	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Skin laceration	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Stent occlusion	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Vascular graft complication	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Metabolism and nutrition disorders Dehydration	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Metabolism and nutrition disorders Diabetic foot	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Metabolism and nutrition disorders Diabetic ketoacidosis	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Metabolism and nutrition disorders Hyperglycaemia	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Metabolism and nutrition disorders Hypoglycaemia	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Metabolism and nutrition disorders Hypokalaemia	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Metabolism and nutrition disorders Hyponatraemia	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Musculoskeletal and connective tissue disorders Back pain	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/264 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 7/264 • Number of events 8 • 3 Years	3.3% 2/61 • Number of events 3 • 3 Years
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 2 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Carotid artery occlusion	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Carotid artery stenosis	1.1% 3/264 • Number of events 4 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Cerebellar haemorrhage	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Cerebral infarction	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Nervous system disorders Cerebrovascular accident	0.76% 2/264 • Number of events 2 • 3 Years	3.3% 2/61 • Number of events 4 • 3 Years
Nervous system disorders Dizziness	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Nervous system disorders Embolic stroke	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Facial palsy	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Haemorrhage intracranial	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Neuropathy peripheral	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Nervous system disorders Peroneal nerve palsy	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Nervous system disorders Presyncope	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Speech disorder	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Syncope	1.5% 4/264 • Number of events 4 • 3 Years	4.9% 3/61 • Number of events 4 • 3 Years
Psychiatric disorders Completed suicide	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Psychiatric disorders Confusional state	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Psychiatric disorders Mental status changes	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Renal and urinary disorders Haematuria	0.38% 1/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Renal and urinary disorders Malignant renal hypertension	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Renal and urinary disorders Renal failure	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Renal and urinary disorders Renal failure acute	1.1% 3/264 • Number of events 3 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Renal and urinary disorders Renal failure chronic	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Renal and urinary disorders Urinary retention	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.1% 3/264 • Number of events 3 • 3 Years	1.6% 1/61 • Number of events 4 • 3 Years
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.3% 6/264 • Number of events 7 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.38% 1/264 • Number of events 1 • 3 Years	4.9% 3/61 • Number of events 5 • 3 Years
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Respiratory, thoracic and mediastinal disorders Epistaxis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 4/264 • Number of events 4 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Skin and subcutaneous tissue disorders Angioedema	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Skin and subcutaneous tissue disorders Dermatitis allergic	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Skin and subcutaneous tissue disorders Skin ulcer	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Surgical and medical procedures Large intestine anastomosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Aortic aneurysm	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Aortic stenosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Arterial restenosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Arterial stenosis limb	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Vascular disorders Arterial thrombosis limb	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Arteriosclerosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Arteriovenous fistula	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Deep vein thrombosis	0.76% 2/264 • Number of events 2 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Vascular disorders Femoral arterial stenosis	1.5% 4/264 • Number of events 4 • 3 Years	4.9% 3/61 • Number of events 3 • 3 Years
Vascular disorders Femoral artery occlusion	1.1% 3/264 • Number of events 3 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Haemorrhage	0.76% 2/264 • Number of events 2 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Hypertension	0.38% 1/264 • Number of events 1 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Vascular disorders Hypertensive crisis	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Vascular disorders Hypotension	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Vascular disorders Iliac artery stenosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Intermittent claudication	6.4% 17/264 • Number of events 20 • 3 Years	6.6% 4/61 • Number of events 5 • 3 Years
Vascular disorders Leriche syndrome	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Malignant hypertension	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Orthostatic hypotension	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Peripheral arterial occlusive disease	4.2% 11/264 • Number of events 14 • 3 Years	3.3% 2/61 • Number of events 4 • 3 Years
Vascular disorders Peripheral artery aneurysm	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Peripheral artery dissection	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Peripheral ischaemia	2.7% 7/264 • Number of events 8 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Vascular disorders Peripheral vascular disorder	4.5% 12/264 • Number of events 17 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Vascular disorders Vascular pseudoaneurysm	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Venous stasis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
General disorders Impaired healing	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Postoperative wound infection	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Staphylococcal bacteraemia	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Infections and infestations Wound infection	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Injury, poisoning and procedural complications Graft dysfunction	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Nervous system disorders Carotid artery disease	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Vascular disorders Thrombophlebitis superficial	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/264 • 3 Years	1.6% 1/61 • Number of events 1 • 3 Years
Cardiac disorders Cardio-respiratory arrest	0.38% 1/264 • Number of events 1 • 3 Years	0.00% 0/61 • 3 Years

Other adverse events

Other adverse events
Measure	Supera® Peripheral Stent System ITT n=264 participants at risk Implantation of Supera stent using the Supera® Peripheral Stent System. ITT population consisted of 264 subjects.	Supera® Peripheral Stent System Roll-in n=61 participants at risk Implantation of Supera stent using the Supera® Peripheral Stent System. There were a total of 61 roll-in subjects.
Blood and lymphatic system disorders Anaemia	5.7% 15/264 • Number of events 16 • 3 Years	3.3% 2/61 • Number of events 2 • 3 Years
Cardiac disorders Coronary artery disease	6.4% 17/264 • Number of events 22 • 3 Years	3.3% 2/61 • Number of events 3 • 3 Years
General disorders Catheter site haematoma	6.1% 16/264 • Number of events 17 • 3 Years	4.9% 3/61 • Number of events 4 • 3 Years
General disorders Chest pain	7.6% 20/264 • Number of events 25 • 3 Years	9.8% 6/61 • Number of events 6 • 3 Years
General disorders Oedema peripheral	7.2% 19/264 • Number of events 21 • 3 Years	11.5% 7/61 • Number of events 8 • 3 Years
Injury, poisoning and procedural complications In-stent arterial restenosis	10.6% 28/264 • Number of events 37 • 3 Years	9.8% 6/61 • Number of events 7 • 3 Years
Musculoskeletal and connective tissue disorders Pain in extremity	15.5% 41/264 • Number of events 51 • 3 Years	26.2% 16/61 • Number of events 20 • 3 Years
Vascular disorders Femoral artery dissection	11.0% 29/264 • Number of events 32 • 3 Years	9.8% 6/61 • Number of events 6 • 3 Years
Vascular disorders Intermittent claudication	14.8% 39/264 • Number of events 52 • 3 Years	11.5% 7/61 • Number of events 13 • 3 Years
Vascular disorders Peripheral arterial occlusive disease	6.4% 17/264 • Number of events 22 • 3 Years	4.9% 3/61 • Number of events 5 • 3 Years
Vascular disorders Peripheral vascular disorder	6.1% 16/264 • Number of events 24 • 3 Years	4.9% 3/61 • Number of events 4 • 3 Years
Cardiac disorders Atrial fibrillation	1.5% 4/264 • Number of events 5 • 3 Years	6.6% 4/61 • Number of events 5 • 3 Years
Cardiac disorders Cardiac failure congestive	3.8% 10/264 • Number of events 15 • 3 Years	6.6% 4/61 • Number of events 6 • 3 Years
Gastrointestinal disorders Nausea	3.0% 8/264 • Number of events 9 • 3 Years	6.6% 4/61 • Number of events 4 • 3 Years
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 12/264 • Number of events 13 • 3 Years	8.2% 5/61 • Number of events 5 • 3 Years
Musculoskeletal and connective tissue disorders Back pain	4.2% 11/264 • Number of events 12 • 3 Years	6.6% 4/61 • Number of events 4 • 3 Years
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.9% 13/264 • Number of events 13 • 3 Years	9.8% 6/61 • Number of events 10 • 3 Years
Vascular disorders Hypertension	2.7% 7/264 • Number of events 7 • 3 Years	4.9% 3/61 • Number of events 3 • 3 Years
Infections and infestations Pneumonia	3.8% 10/264 • Number of events 11 • 3 Years	6.6% 4/61 • Number of events 4 • 3 Years

Additional Information

Margo Zaugg

Abbott Vascular

Phone: 408-845-0576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60