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

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

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

The EMINENT study is a prospective, multi-center study evaluating the 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 evaluate the 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.

Inclusion Criteria:

1. Subjects age 18 and older

2. 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

3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

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

5. 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:

1. Previously stented target lesion/vessel
2. Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to randomization/enrollment
3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
4. Use of atherectomy, laser or other debulking devices such as Rotarex in the target limb SFA/PPA during the index procedure
5. History of major amputation in the target limb
6. 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
7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
8. 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)
9. Platelet count less than 80000 mm3 or more than 600000 mm3 or history of bleeding diathesis
10. Concomitant renal failure with a serum creatinine higher than 2.0 mg/dL
11. Receiving dialysis or immunosuppressant therapy
12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment
13. Unstable angina pectoris at the time of randomization/enrollment
14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years
15. 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)
16. Septicemia at the time of randomization/enrollment
17. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention at the time of the index procedure
18. Presence of aneurysm in the target vessel
19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment
20. Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment
21. Heavily calcified lesions
22. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person