NCT02921230已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 775
- 试验地点
- 114
- 主要终点
- Number of Subjects With Primary Patency at 12 Months Post-procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Subjects With Primary Patency at 12 Months Post-procedure
时间窗: 12 Months
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.
次要结局
- Number of Subjects Walking Improvement - Distance at Baseline to 12 Months(12 Months)
- Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month(12 Months)
- Cost Effectiveness(during index procedure, 1, 6, 12, 24 and 36 months)
- Number of Subjects With Clinical Improvement at 12-months(12 months)
- Number of Subjects With Hemodynamic Improvement at 12-months(12 months)
研究者
研究点 (114)
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