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

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