Trial Outcomes & Findings for ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent (NCT NCT02574481)

Last Updated: 2023-05-08

Results Overview

MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

524 participants

Primary outcome timeframe

12 Months

Results posted on

2023-05-08

Participant Flow

A total of 524 subjects have been enrolled in the IMPERIAL trial, including 465 subjects in the RCT, 50 subjects in the LL substudy and 13 subjects in the PK substudy. There were 4 subjects enrolled in both the PK and Long Lesion substudy.

Participant milestones

Participant milestones
Measure	ELUVIA Stent Implantation Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy Long Lesions Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Overall Study STARTED	309	156	50	13
Overall Study COMPLETED	195	102	25	8
Overall Study NOT COMPLETED	114	54	25	5

Reasons for withdrawal

Reasons for withdrawal
Measure	ELUVIA Stent Implantation Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy Long Lesions Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Overall Study Withdrawal by Subject	29	15	4	1
Overall Study Adverse Event	5	1	1	0
Overall Study Visit Missed	15	7	5	0
Overall Study Other	7	2	0	0
Overall Study Death	48	26	12	4
Overall Study Physician Decision	5	2	0	0
Overall Study Lost to Follow-up	5	1	3	0

Baseline Characteristics

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELUVIA Stent Implantation n=309 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=156 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=50 Participants Long Lesion Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy n=13 Participants PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.	Total n=528 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 9.5 • n=5 Participants	67.8 years STANDARD_DEVIATION 9.4 • n=7 Participants	68.2 years STANDARD_DEVIATION 8.9 • n=5 Participants	66.4 years STANDARD_DEVIATION 6.1 • n=4 Participants	68.3 years STANDARD_DEVIATION 9.3 • n=21 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	52 Participants n=7 Participants	18 Participants n=5 Participants	3 Participants n=4 Participants	178 Participants n=21 Participants
Sex: Female, Male Male	204 Participants n=5 Participants	104 Participants n=7 Participants	32 Participants n=5 Participants	10 Participants n=4 Participants	350 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	18 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	27 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	205 Participants n=5 Participants	108 Participants n=7 Participants	30 Participants n=5 Participants	13 Participants n=4 Participants	356 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Japanese	56 Participants n=5 Participants	28 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	95 Participants n=21 Participants
Race/Ethnicity, Customized Black, or African Heritage	21 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	38 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Not Disclosed	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment New Zealand	9 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	15 participants n=21 Participants
Region of Enrollment Canada	17 participants n=5 Participants	7 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	24 participants n=21 Participants
Region of Enrollment Europe	89 participants n=5 Participants	44 participants n=7 Participants	4 participants n=5 Participants	0 participants n=4 Participants	137 participants n=21 Participants
Region of Enrollment United States	138 participants n=5 Participants	72 participants n=7 Participants	34 participants n=5 Participants	13 participants n=4 Participants	257 participants n=21 Participants
Region of Enrollment Japan	56 participants n=5 Participants	28 participants n=7 Participants	11 participants n=5 Participants	0 participants n=4 Participants	95 participants n=21 Participants
History of Smoking (Current)	109 Participants n=5 Participants	63 Participants n=7 Participants	16 Participants n=5 Participants	3 Participants n=4 Participants	191 Participants n=21 Participants
History of Smoking (Previous)	157 Participants n=5 Participants	68 Participants n=7 Participants	26 Participants n=5 Participants	10 Participants n=4 Participants	261 Participants n=21 Participants
History of Smoking (Never)	42 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	72 Participants n=21 Participants
History of Smoking (Unknown)	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Current Diabetes Mellitus	129 Participants n=5 Participants	68 Participants n=7 Participants	20 Participants n=5 Participants	7 Participants n=4 Participants	224 Participants n=21 Participants
History of Hyperlipidemia requiring medication	235 Participants n=5 Participants	118 Participants n=7 Participants	41 Participants n=5 Participants	12 Participants n=4 Participants	406 Participants n=21 Participants
History of Hypertension requiring medication	254 Participants n=5 Participants	133 Participants n=7 Participants	46 Participants n=5 Participants	12 Participants n=4 Participants	445 Participants n=21 Participants
History of Chronic Obstructive Pulmonary Disease	48 Participants n=5 Participants	28 Participants n=7 Participants	9 Participants n=5 Participants	2 Participants n=4 Participants	87 Participants n=21 Participants
History of Coronary Artery Disease (CAD)	156 Participants n=5 Participants	70 Participants n=7 Participants	28 Participants n=5 Participants	7 Participants n=4 Participants	261 Participants n=21 Participants
History of Myocardial Infarction (MI)	60 Participants n=5 Participants	27 Participants n=7 Participants	9 Participants n=5 Participants	2 Participants n=4 Participants	98 Participants n=21 Participants
History of Congestive Heart Failure (CHF)	26 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	1 Participants n=4 Participants	47 Participants n=21 Participants
History of Percutaneous Coronary Intervention (PCI)	100 Participants n=5 Participants	53 Participants n=7 Participants	18 Participants n=5 Participants	3 Participants n=4 Participants	174 Participants n=21 Participants
History of Coronary Artery Bypass Surgery (CABG)	43 Participants n=5 Participants	21 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	74 Participants n=21 Participants
Stable Angina	32 Participants n=5 Participants	19 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	56 Participants n=21 Participants
History of Transient Ischemic Attacks (TIA)	14 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	26 Participants n=21 Participants
History of Cerebrovascular Accident (CVA)	30 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	57 Participants n=21 Participants
History of Renal insufficiency	25 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	41 Participants n=21 Participants
History of Renal Percutaneous Intervention	6 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
History of Peripheral Vascular Surgery	40 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	58 Participants n=21 Participants
History of endovascular interventions in Target Vessel	27 Participants n=5 Participants	17 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	47 Participants n=21 Participants
History of Other Peripheral Endovascular Interventions (other than Target Vessel)	112 Participants n=5 Participants	49 Participants n=7 Participants	20 Participants n=5 Participants	5 Participants n=4 Participants	186 Participants n=21 Participants
History of Claudication	303 Participants n=5 Participants	151 Participants n=7 Participants	49 Participants n=5 Participants	13 Participants n=4 Participants	516 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 Months

MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=287 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=132 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=50 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy n=13 Participants To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Percentage of Participants With Major Adverse Events (MAEs) All Causes of Death at 1 Month	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAEs) Target Limb Major Amputation	0.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAEs) Target Lesion Revascularization	4.5 percentage of participants	9.0 percentage of participants	6.5 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 12 Months

Population: Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or, bypass of the target lesion before or on the DUS FU visit. Per PK sub-study design, primary efficacy (patency) not analyzed.

Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=266 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=130 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=46 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Number of Participants Reaching Primary Patency	231 Participants	106 Participants	40 Participants	—

SECONDARY outcome

Timeframe: 12 Months

Population: Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.

Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=292 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=150 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=46 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy n=13 Participants To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Number of CEC-adjudicated Events Through 12 Months Target Vessel Revascularization	20 participants	13 participants	4 participants	0 participants
Number of CEC-adjudicated Events Through 12 Months All deaths	6 participants	6 participants	0 participants	0 participants
Number of CEC-adjudicated Events Through 12 Months Target Lesion Revascularization	13 participants	13 participants	3 participants	1 participants
Number of CEC-adjudicated Events Through 12 Months Target Limb Amputation	1 participants	2 participants	0 participants	0 participants
Number of CEC-adjudicated Events Through 12 Months Stent Thrombosis	5 participants	6 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 Months

Population: Per PK sub-study design, secondary endpoint not analyzed.

Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=279 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=142 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=47 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Count of Participants Meeting Primary Sustained Clinical Improvement	250 Participants	118 Participants	35 Participants	—

SECONDARY outcome

Timeframe: 12 Months

Population: Per PK sub-study design, secondary endpoint not analyzed.

Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=276 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=141 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=45 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Number of Participants With Hemodynamic Improvement	223 Participants	111 Participants	37 Participants	—

SECONDARY outcome

Timeframe: Baseline to 12 Months

Population: Not all subjects were able to complete questionnaires.Per PK sub-study design, secondary endpoint not analyzed.

The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=279 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=141 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=47 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Walking Impairment Questionnaire (WIQ) Scores Stair climbing	19.43 Units on a scale Standard Deviation 36.68	21.10 Units on a scale Standard Deviation 34.55	56.29 Units on a scale Standard Deviation 34.55	—
Walking Impairment Questionnaire (WIQ) Scores Distance	33.16 Units on a scale Standard Deviation 38.33	29.49 Units on a scale Standard Deviation 38.19	58.67 Units on a scale Standard Deviation 36.60	—
Walking Impairment Questionnaire (WIQ) Scores Speed	18.25 Units on a scale Standard Deviation 29.46	18.08 Units on a scale Standard Deviation 28.72	41.21 Units on a scale Standard Deviation 25.95	—

SECONDARY outcome

Timeframe: Change in baseline to 12-Months

Population: Per PK sub-study design, secondary endpoint not analyzed.

Change in distance walked from baseline to 12 months.

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=269 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=136 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=42 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
6-Minute Walk Test - Distance Walked	323.8 m Standard Deviation 148.5	323.4 m Standard Deviation 155.4	293.5 m Standard Deviation 123.8	—

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Per PK sub-study design, secondary endpoint not analyzed.

Change in speed walked from baseline to 12 months

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=269 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=136 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=42 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
6-Minute Walk Test - Speed	55.5 m/min Standard Deviation 23.3	56.1 m/min Standard Deviation 24.1	50.3 m/min Standard Deviation 19.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 60 Months

Population: PK Substudy cohort was not included in this outcome

Percentage of participants without Major Adverse Events (MAEs)

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=232 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=114 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=35 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Freedom From Major Adverse Events	156 Participants	74 Participants	19 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 60 Months

Population: PK Substudy cohort was not included in this outcome

Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=273 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=139 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=46 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate	68 Participants	39 Participants	15 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through 60 Months

Population: PK Substudy cohort was not included in this outcome

Clinical Events Committee (CEC) adjudicated target limb major amputation rate

Outcome measures

Outcome measures
Measure	ELUVIA Stent Implantation n=273 Participants Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=139 Participants Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=46 Participants To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy To further evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Percentage of Participants With Target Limb Major Amputation	8 Participants	3 Participants	0 Participants	0 Participants

Adverse Events

ELUVIA Stent Implantation

Serious events: 243 serious events

Other events: 186 other events

Deaths: 58 deaths

Zilver PTX Stent Implantation

Serious events: 126 serious events

Other events: 91 other events

Deaths: 28 deaths

Long Lesion Substudy

Serious events: 40 serious events

Other events: 27 other events

Deaths: 13 deaths

PK Substudy

Serious events: 13 serious events

Other events: 11 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Nicole Kilburn

Boston Scientific

Phone: 970-294-4082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	ELUVIA Stent Implantation n=309 participants at risk Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=156 participants at risk Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=50 participants at risk To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy n=13 participants at risk To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Injury, poisoning and procedural complications Laceration	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Injury, poisoning and procedural complications Spinal compression fracture	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Injury, poisoning and procedural complications Wound	0.65% 2/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral artery stenosis	27.5% 85/309 • Number of events 144 • Adverse event data were collected to five year (60M) post-implant.	26.9% 42/156 • Number of events 73 • Adverse event data were collected to five year (60M) post-implant.	20.0% 10/50 • Number of events 14 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Intermittent claudication	11.7% 36/309 • Number of events 55 • Adverse event data were collected to five year (60M) post-implant.	8.3% 13/156 • Number of events 20 • Adverse event data were collected to five year (60M) post-implant.	18.0% 9/50 • Number of events 14 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 9 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral arterial occlusive disease	8.7% 27/309 • Number of events 42 • Adverse event data were collected to five year (60M) post-implant.	9.6% 15/156 • Number of events 19 • Adverse event data were collected to five year (60M) post-implant.	6.0% 3/50 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Femoral artery occlusion	8.7% 27/309 • Number of events 35 • Adverse event data were collected to five year (60M) post-implant.	3.8% 6/156 • Number of events 8 • Adverse event data were collected to five year (60M) post-implant.	8.0% 4/50 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral artery thrombosis	4.5% 14/309 • Number of events 19 • Adverse event data were collected to five year (60M) post-implant.	2.6% 4/156 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Extremity necrosis	0.65% 2/309 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral vascular disorder	0.97% 3/309 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	1.3% 2/156 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Haematoma	0.97% 3/309 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral embolism	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Arterial spasm	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Arteriosclerosis	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Embolism	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Subclavian artery stenosis	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral ischaemia	1.6% 5/309 • Number of events 7 • Adverse event data were collected to five year (60M) post-implant.	5.1% 8/156 • Number of events 9 • Adverse event data were collected to five year (60M) post-implant.	4.0% 2/50 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Aortic aneurysm	1.3% 4/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	1.3% 2/156 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Angina pectoris	4.5% 14/309 • Number of events 18 • Adverse event data were collected to five year (60M) post-implant.	5.1% 8/156 • Number of events 9 • Adverse event data were collected to five year (60M) post-implant.	4.0% 2/50 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Coronary artery disease	4.9% 15/309 • Number of events 16 • Adverse event data were collected to five year (60M) post-implant.	2.6% 4/156 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	4.0% 2/50 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Atrial fibrillation	5.2% 16/309 • Number of events 17 • Adverse event data were collected to five year (60M) post-implant.	3.8% 6/156 • Number of events 6 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Cardiac Failure	4.5% 14/309 • Number of events 15 • Adverse event data were collected to five year (60M) post-implant.	3.2% 5/156 • Number of events 5 • Adverse event data were collected to five year (60M) post-implant.	10.0% 5/50 • Number of events 6 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Acute myocardial infarction	4.2% 13/309 • Number of events 15 • Adverse event data were collected to five year (60M) post-implant.	3.8% 6/156 • Number of events 6 • Adverse event data were collected to five year (60M) post-implant.	4.0% 2/50 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	15.4% 2/13 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Coronary artery stenosis	1.3% 4/309 • Number of events 5 • Adverse event data were collected to five year (60M) post-implant.	1.9% 3/156 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Angina unstable	1.9% 6/309 • Number of events 11 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Cardiac failure congestive	2.3% 7/309 • Number of events 9 • Adverse event data were collected to five year (60M) post-implant.	1.9% 3/156 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Cardiac arrest	1.6% 5/309 • Number of events 5 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Atrial flutter	0.97% 3/309 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Ischaemic cardiomyopathy	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Myocardial infarction	1.9% 6/309 • Number of events 7 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Myocardial ischaemia	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Cardiac failure chronic	0.97% 3/309 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	1.9% 3/156 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Cardiopulmonary failure	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	1.3% 2/156 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Mitral valve incompetence	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Tricuspid valve stenosis	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Infections and infestations Pneumonia	5.2% 16/309 • Number of events 19 • Adverse event data were collected to five year (60M) post-implant.	9.6% 15/156 • Number of events 17 • Adverse event data were collected to five year (60M) post-implant.	16.0% 8/50 • Number of events 10 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.

Other adverse events
Measure	ELUVIA Stent Implantation n=309 participants at risk Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Zilver PTX Stent Implantation n=156 participants at risk Percutaneous stent placement in the SFA/PPA Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	Long Lesion Substudy n=50 participants at risk To evaluate the safety and effectiveness of the ELUVIA Stent for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.	PK Substudy n=13 participants at risk To evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent.
Renal and urinary disorders Dysuria	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Cardiac disorders Coronary artery disease	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Investigations Ankle brachial index decreased	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Investigations Blood pressure increased	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Groin pain	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Investigations Prostatic specific antigen increased	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Tendonitis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	1.3% 2/156 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 11/309 • Number of events 13 • Adverse event data were collected to five year (60M) post-implant.	3.8% 6/156 • Number of events 7 • Adverse event data were collected to five year (60M) post-implant.	6.0% 3/50 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Muscle spasms	1.3% 4/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	1.9% 3/156 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.3% 4/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Exostosis	1.3% 4/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Back pain	1.3% 4/309 • Number of events 4 • Adverse event data were collected to five year (60M) post-implant.	3.2% 5/156 • Number of events 5 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	2.0% 1/50 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Bursitis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Joint swelling	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Limb discomfort	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Muscular weakness	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Osteoporosis	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Trigger finger	0.65% 2/309 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Arthritis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Costochondritis	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Flank pain	0.32% 1/309 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/156 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Osteochondritis	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/309 • Adverse event data were collected to five year (60M) post-implant.	0.64% 1/156 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/50 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Peripheral artery stenosis	5.8% 18/309 • Number of events 22 • Adverse event data were collected to five year (60M) post-implant.	3.8% 6/156 • Number of events 6 • Adverse event data were collected to five year (60M) post-implant.	6.0% 3/50 • Number of events 3 • Adverse event data were collected to five year (60M) post-implant.	0.00% 0/13 • Adverse event data were collected to five year (60M) post-implant.
Vascular disorders Intermittent claudication	3.2% 10/309 • Number of events 10 • Adverse event data were collected to five year (60M) post-implant.	7.1% 11/156 • Number of events 11 • Adverse event data were collected to five year (60M) post-implant.	4.0% 2/50 • Number of events 2 • Adverse event data were collected to five year (60M) post-implant.	7.7% 1/13 • Number of events 1 • Adverse event data were collected to five year (60M) post-implant.