Trial Comparing ELUVIA Versus Bare Metal Stent in Treatme... | NCT02921230

Label	Type	Description	Intervention Names
ELUVIA Stent Implantation	Experimental	Peripheral stenting	Device: Peripheral stenting
control Bare Metal Stent Implantation	Active Comparator	Peripheral stenting	Device: Peripheral stenting

Name	Type	Description	Arm Group Labels	Other Names
Peripheral stenting	Device	stent implantation during the index procedure	ELUVIA Stent Implantation control Bare Metal Stent Implantation

Measure	Description	Time Frame
Number of Subjects With Primary Patency at 12 Months Post-procedure	The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.	12 Months

Measure	Description	Time Frame
Number of Subjects Walking Improvement - Distance at Baseline to 12 Months	Walking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline. Values are represented as a mean and standard deviation and reflect the change in meters walked.

Measure	Description	Time Frame
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months	Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months assessed by change in Walking Impairment Questionnaire (WIQ) from baseline.	1, 6, 12, 24, and 36 months
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects age 18 and older
Subject is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
Stenotic, restenotic or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA):
1. Degree of stenosis ≥ 70 % by visual angiographic assessment
2. Vessel diameter ≥ 4 and ≤ 6 mm
3. Total lesion length (or series of lesions) ≥ 30 mm and ≤210 mm (Note: Lesion segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) or Self Expanding Bare Nitinol stent(s))
4. For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm
5. Target lesion located at least three centimeters above the inferior edge of the femur
Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50 % stenosis) to the ankle or foot with no planned intervention

Exclusion Criteria:

Previously stented target lesion/vessel
Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to randomization/enrollment
Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
Use of atherectomy, laser or other debulking devices such as Rotarex in the target limb SFA/PPA during the index procedure
History of major amputation in the target limb
Documented life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study
Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
Known hypersensitivity/allergy to the stent system or protocol related therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual components, and antiplatelet, anticoagulant, thrombolytic medications)
Platelet count less than 80000 mm3 or more than 600000 mm3 or history of bleeding diathesis
Concomitant renal failure with a serum creatinine higher than 2.0 mg/dL
Receiving dialysis or immunosuppressant therapy
History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment
Unstable angina pectoris at the time of randomization/enrollment
Pregnant, breast feeding, or plan to become pregnant in the next 5 years
Current participation in an investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/ enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
Septicemia at the time of randomization/enrollment
Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention at the time of the index procedure
Presence of aneurysm in the target vessel
Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment
Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment
Heavily calcified lesions
As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person

Name	Affiliation	Role
Giovanni Torsello, MD	Sint-Franziskus-Hospital GmbH	Principal Investigator
Yann Goueffic	Hôpital St Joseph Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
LKH Innsbruck		Innsbruck		6020	Austria
Klinikum Klagenfurt

PubMed Identifier	Type	Citation	Retractions
36254728	Derived	Goueffic Y, Torsello G, Zeller T, Esposito G, Vermassen F, Hausegger KA, Tepe G, Thieme M, Gschwandtner M, Kahlberg A, Schindewolf M, Sapoval M, Diaz-Cartelle J, Stavroulakis K; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022 Nov 22;146(21):1564-1576. doi: 10.1161/CIRCULATIONAHA.122.059606. Epub 2022 Oct 18.

ID	Title	Description
FG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
FG001	Control Bare Metal Stent Implantation

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan: Protocol	Dec 23, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.9± 8.7 BG00168.9± 9.1 BG00268.9± 8.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000145 BG00187 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Austria

Title	Measurements
	BG00053 BG00128 BG002

History of Smoking

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Current	BG000183 BG00196 BG002

Current Diabetes Mellitus

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000180 BG00196 BG002

History of Hyperlipidemia requiring medication

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000341 BG001182 BG002

History of Hypertension requiring medication

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000397 BG001203 BG002

History of Chronic Obstructive Pulmonary Disease

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00065 BG00133 BG002

History of Coronary Artery Disease

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000159 BG00196 BG002

History of Myocardial Infarction (MI)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00075 BG00141 BG002

History of Congestive Heart Failure

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00035 BG00113 BG002

History of Percutaneous Coronary Intervention (PCI)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000114 BG00167 BG002

History of Coronary Artery Bypass Graft (CABG) Surgery

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00050 BG00130 BG002

Current Anginal Status

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Stable Angina	BG00019 BG0017 BG002

History of Transient Ischemic Attacks (TIA)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00029 BG00111 BG002

History of Cerebrovascular Accident (CVA)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00038 BG00115 BG002

History of Renal Insufficiency

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00059 BG00122 BG002

History of Renal Percutaneous Intervention

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0006 BG0015 BG002

History of Endovascular Interventions in Target Vessel

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00036 BG00125 BG002

History of Other Peripheral Endovascular Interventions (other than Target Vessel)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000147 BG00186 BG002

History of Claudication

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000447 BG001228 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Primary Patency at 12 Months Post-procedure

The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.

Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 12 months in the absence of clinically-driven Target Lesion Revascularization (TLR) or bypass of the target lesion.

405/508 subjects in Eluvia and 222/267 subjects in the control arm.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants	OG000405 OG001222

Title

Denominators

Categories

Title	Measurements
	OG000337 OG001165

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.0077														Superiority

Secondary

Number of Subjects Walking Improvement - Distance at Baseline to 12 Months

Walking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline.

Values are represented as a mean and standard deviation and reflect the change in meters walked.

Posted

Mean

Standard Deviation

Meter

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Secondary

Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month

The change in quality of life will be assessed and compared between the 2 study arms, by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline, or preceding any Target Vessel Revascularization Values are presented as a count of subjects at 12-months and by the number of subjects analyzed.

The number analyzed for each row is based on the number of subjects that completed the portion of the quality-of-life assessment during the visit.

Posted

Count of Participants

Participants

12 Months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Secondary

Cost Effectiveness

Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents.

Cost effectiveness was not collected for the study as this data was an optional health economics data analysis.

Posted

during index procedure, 1, 6, 12, 24 and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Peripheral stenting Peripheral stenting: stent implantation during the index procedure
OG001	Control Bare Metal Stent Implantation	Peripheral stenting Peripheral stenting: stent implantation during the index procedure

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Clinical Improvement at 12-months

Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline.

Values are presented as a count of participants at 12-months by the number of participants analyzed.

Rutherford Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings;

Primary sustained clinical improvement, is a rate of improvement in Rutherford classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR);

Secondary sustained clinical improvement is a rate of improvement in Rutherford classification of one or more categories as compared to baseline including those subjects with repeat TLR;

Clinical deterioration, is the rate of downgrade in Rutherford classification of one or more categories as compared to baseline

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Secondary

Number of Subjects With Hemodynamic Improvement at 12-months

Hemodynamic improvement was evaluated by assessing the number of participants that demonstrated an increase in the Ankle-Brachial Index value of >/= 0.10 or an increase in the overall ABI value to >/= 0.90 from baseline to 12 months

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants	OG000

Other Pre-specified

Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months

Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months assessed by change in Walking Impairment Questionnaire (WIQ) from baseline.

The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.

Posted

Count of Participants

Participants

1, 6, 12, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months

Quality of Life Improvement will be assessed at 1-month, 6-months, 24-months, and 36-months by evaluating the change in EQ-5D-5L™ from baseline

The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.

Posted

Count of Participants

Participants

1, 6, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months

Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline

The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.

Posted

Count of Participants

Participants

1, 6, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months

The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline

The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.

Posted

Count of Participants

Participants

1, 6, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Primary Patency and Assisted Primary Patency

Primary Patency and Assisted Primary Patency at 6 months, 12 months using different Duplex Ultrasound (DUS) and Peak Systolic Velocity Ration (PSVRs). All DUS readings will be assessed by an independent core laboratory. Primary Patency is reported at 6 and 12-months.

The number analyzed indicates the subjects with available diagnostic duplex ultrasound images.

Posted

Count of Participants

Participants

6 and 12 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Adverse Event and Major Adverse Event (MAE) Rate

Adverse Event rate and Major Adverse Event rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization, rate at each time point

The number Started in Participant Flow indicates the intent-to-treat population while the number analyzed indicates the as-treated (AT) population. For AT analysis, subjects implanted are included based on the actual Test or Control device each subject received (including cross-over subjects). Only study permitted stents are included in the AT set.

The number analyzed in the data table differs from the overall analyzed as it indicates subjects that reached the lower limit for the visit window.

Posted

Count of Participants

Participants

1, 6, 12, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Other Pre-specified

Clinically-driven Target Lesion Revascularization (TLR) Rate

Target Lesion Revascularization, defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure, rate at each time point.

The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.

For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).

The number analyzed in the rows below differs from the overall analyzed as it indicates the subjects that reached the lower limit for the visit window.

Posted

Count of Participants

Participants

1, 6, 12, 24, and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Other Pre-specified

Clinically-driven Target Vessel Revascularization (TVR) Rate

Target Vessel Revascularization, defined as any surgical or percutaneous intervention to the target vessel after the index procedure, rate at each time point.

The number analyzed indicates the subjects that reached the lower limit for the visit window.

Posted

Count of Participants

Participants

1, 6, 12, 24 and 36 months

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants

Other Pre-specified

Technical Success

Technical success defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually

The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.

For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).

Posted

Count of Participants

Participants

during index procedure after stent delivered and deployed to the target lesion

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Other Pre-specified

Procedural Success

Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure

The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.

For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).

Posted

Count of Participants

Participants

within 24 hours of stenting procedure

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts

Other Pre-specified

Number of Stent Fractures

Number of Stent Fractures reported at 12 months utilizing the Vascular InterVentional Advances (VIVA) definitions assessed by an independent core laboratory.

Stent fractures were analyzed if sites collected imaging per standard of care (SOC).

Posted

Count of Units

Stents

12 Months

Stents

ID	Title	Description
OG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
OG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peripheral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG00040 events32 affected492 at risk EG0016 events5 affected273 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG00038 events32 affected492 at risk EG00119 events17 affected273 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG00012 events11 affected492 at risk EG0013 events3 affected273 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0005 events5 affected492 at risk EG0011 events1 affected273 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events3 affected492 at risk EG0010 events0 affected273 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0011 events1 affected273 at risk
Peripheral embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0011 events1 affected273 at risk
Arterial disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Reperfusion injury	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Vascular dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Femoral artery dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0012 events2 affected273 at risk
Vascular stent restenosis	General disorders	MedDRA	Systematic Assessment	EG00021 events21 affected492 at risk EG00128 events19 affected273 at risk
Vascular stent thrombosis	General disorders	MedDRA	Systematic Assessment	EG00014 events12 affected492 at risk EG0016 events6 affected273 at risk
Vascular stent stenosis	General disorders	MedDRA	Systematic Assessment	EG00011 events10 affected492 at risk EG00111 events10 affected273 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG00011 events11 affected492 at risk EG0016 events6 affected273 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Necrosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Stenosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0014 events4 affected273 at risk
Device embolisation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Puncture site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0007 events7 affected492 at risk EG0014 events4 affected273 at risk
Reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 events6 affected492 at risk EG0011 events1 affected273 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0009 events9 affected492 at risk EG00113 events9 affected273 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events1 affected492 at risk EG0010 events0 affected273 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Vascular access site pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Device occlusion	Product Issues	MedDRA	Systematic Assessment	EG00023 events20 affected492 at risk EG0016 events6 affected273 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0006 events6 affected492 at risk EG0011 events1 affected273 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Post procedural sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0011 events1 affected273 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0012 events2 affected273 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected492 at risk EG0010 events0 affected273 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Completed Suicide	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Arterial haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Venous stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Arterial stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Vascular stent occlusion	General disorders	MedDRA	Systematic Assessment	EG00011 events9 affected492 at risk EG0012 events2 affected273 at risk
Catheter site inflammation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Inflammation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Peripheral arterial reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected492 at risk EG0010 events0 affected273 at risk
Corona virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0011 events1 affected273 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected492 at risk EG0010 events0 affected273 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0011 events1 affected273 at risk
Idiopathic interstitial pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG00013 events11 affected492 at risk EG0017 events7 affected273 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG00012 events11 affected492 at risk EG0015 events5 affected273 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0005 events5 affected492 at risk EG0014 events4 affected273 at risk
Vascular dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events4 affected492 at risk EG0010 events0 affected273 at risk
Femoral artery dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected492 at risk EG0016 events6 affected273 at risk
Artery dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0011 events1 affected273 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Arterial spasm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Peripheral embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Vascular occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Arteriovenus fistula	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Vascular stent restenosis	General disorders	MedDRA	Systematic Assessment	EG0009 events9 affected492 at risk EG00112 events12 affected273 at risk
Vascular stent stenosis	General disorders	MedDRA	Systematic Assessment	EG0005 events5 affected492 at risk EG0014 events4 affected273 at risk
Vessel puncture site haematoma	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected492 at risk EG0013 events3 affected273 at risk
Vascular stent thrombosis	General disorders	MedDRA	Systematic Assessment	EG0005 events5 affected492 at risk EG0011 events1 affected273 at risk
Stenosis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0012 events2 affected273 at risk
Puncture site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0012 events2 affected273 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Puncture site pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Device embolisation	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00010 events10 affected492 at risk EG0012 events2 affected273 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected492 at risk EG0010 events0 affected273 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 events6 affected492 at risk EG0013 events3 affected273 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0011 events1 affected273 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Device occlusion	Product Issues	MedDRA	Systematic Assessment	EG0006 events6 affected492 at risk EG0015 events5 affected273 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Skin maceration	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Contrast media allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk
Contrast media reaction	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected492 at risk EG0011 events1 affected273 at risk
Inflammation	General disorders	MedDRA	Systematic Assessment	EG0007 events7 affected492 at risk EG0010 events0 affected273 at risk
Vascular stent occlusion	General disorders	MedDRA	Systematic Assessment	EG0007 events7 affected492 at risk EG0010 events0 affected273 at risk
Peripheral arterial reocclusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected492 at risk EG0010 events0 affected273 at risk

ID	Term
D001157	Arterial Occlusive Diseases
D050197	Atherosclerosis
D014652	Vascular Diseases
D001161	Arteriosclerosis

ID	Title	Description
BG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.
BG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ELUVIA Stent Implantation	Percutaneous stent placement in the SFA/PPA ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure.	39	508	181	492	109	492
EG001	Control Bare Metal Stent Implantation	Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific)	15	267	90	273	54	273