Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery

Study Overview
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Brief Summary
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The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

Detailed Description
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The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4. The study is a 2:1 randomized (ELUVIA vs Self-Expanding Bare Nitinol Stents), controlled, single-blind, superiority trial (RCT). The objective of the study is to confirm the superior effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 210 mm in length when compared against bare metal stents, and collect additional data including health economics data.

Official Title
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A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

Conditions
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Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis

Intervention / Treatment
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* Device: Peripheral stenting


Participation Criteria
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Eligibility Criteria
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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): Degree of stenosis ≥ 70 % by visual angiographic assessment Vessel diameter ≥ 4 and ≤ 6 mm 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)) For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELUVIA Stent Implantation<br>Peripheral stenting | Device: Peripheral stenting<br>* stent implantation during the index procedure<br>|
| Active Comparator: control Bare Metal Stent Implantation<br>Peripheral stenting | Device: Peripheral stenting<br>* stent implantation during the index procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 vessel patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit in the absence of clinically-driven TLR or bypass of the target lesion. All DUS readings will be assessed by an independent core laboratory. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Improvement | 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 | 12 Months | 
| Change in quality of life | 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 | 12 Months | 
| Cost effectiveness | Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents | during index procedure, 1, 6, 12, 24 and 36 months | 
| Clinical improvement | Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline | 12 months | 
| Hemodynamic improvement | The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), stenting, paclitaxel