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.
Who can participate
Age range18 Years
SexALL
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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
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
What they're measuring
1
Number of Subjects With Primary Patency at 12 Months Post-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)