A Randomized Study Comparing the Edwards Self-ExpandIng LifeStent Versus Angioplasty-alone In LEsions INvolving The SFA and/or Proximal Popliteal Arter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 主要终点
- Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
研究概览
简要总结
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone
详细描述
The RESILIENT Trial is a dual stage clinical investigation designed to evaluate the safety and effectiveness of the Edwards Lifesciences self-expanding stent system.
Phase 1 consists of a prospective, multi-center, non-randomized study with a peri-procedure endpoint. Phase 2 consists of a prospective, multi-center, randomized study with a 30-day primary safety endpoint and a 6-month primary effectiveness endpoint.
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
- None
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
- •Written informed consent approved by the IRB.
- •≥ 18 years old.
- •Lifestyle-limiting claudication defined as: Rutherford Cat. 1-
- •Target lesion(s) is de-novo or restenotic and located within the native SFA and/or proximal popliteal artery
- •Angiographic evidence of ≥ 50% stenosis or occlusion
- •Target RVD is ≥ 4.0 mm and ≤ 7.0 mm
- •Target total length of the lesion or series of lesions is ≤ 150 mm.
- •Angiographic evidence of at least one vessel runoff to the foot.
排除标准
- •Unable to conform to the study protocol procedures and visits.
- •Lifestyle-limiting claudication/CLI (Rutherford Cat. 4-6)
- •Patients who are pregnant or planning to become pregnant during the clinical investigation
- •Contraindication to study related medications, Ni, Ti, Ta, or other media that is not amenable to pretreatment.
- •History of bleeding diatheses or coagulopathy.
- •Concomitant renal failure with a creatinine of > 2.0 mg/dL.
- •Concomitant hepatic insufficiency, thrombophlebitis, uremia, SLE, or DVT at the time of the study procedure.
- •Receiving dialysis or immunosuppressive therapy.
- •Suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure.
- •Prior peripheral vascular bypass surgery involving the target limb.
- •Target vessel has been previously stented.
- •Target lesion(s) received angioplasty intervention ≤ 6 mo. prior
- •Any non-iliac percutaneous intervention(s) < 7 days prior.
- •Currently participating in an investigational drug/device study.
- •Limited life expectancy of less than two years.
- •Extensive PVD that precludes safe insertion of an sheath.
- •Target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
- •Unresolved thrombus within the target vessel.
- •Poor inflow which would not support a vascular bypass graft.
- •Diagnosed with septicemia at the time of the study procedure.
- •Additional percutaneous interventional procedures (cardiac/peripheral) planned ≤ 30 days following procedure.
研究组 & 干预措施
1
PTA Only: Active Comparator
Percutaneous transluminal angioplasty (PTA) alone
干预措施: Percutaneous Transluminal Angioplasty (Other)
2
Test Arm: Experimental
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease.
干预措施: LifeStent NT™ Self-Expanding Peripheral Stent (Device)
结局指标
主要结局
Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
时间窗: 30 Day, 6 Month, and 12 Month
次要结局
- Safety: Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel at 30-days post-procedure. Freedom from 30-day death and 6-month(30 Day, 6 Month and12 Month)