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.
• 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