NCT00712309Unknown不适用
Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions - Balloon Angioplasty Versus Primary Stenting
Herz-Zentrums Bad Krozingen4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
研究概览
简要总结
- Does primary stenting have a lower 12-month restenosis rate than PTA alone in the treatment of atherosclerotic lesions of the popliteal artery?
- Alternative hypothesis: "Primary stenting with the Edwards LifeStent is associated with a lower restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery at 12 months"
- Null hypothesis: "Primary stenting with the Edwards LifeStent is not associated with a lower 12-month restenosis rate than PTA alone in patients with atherosclerotic lesions of the popliteal artery""
- Does comparison of the two intervention groups (PTA alone, stenting) disclose differences in terms of the secondary endpoints?
- How do the intervention methods compare in terms of safety/incidence of adverse effects?
- What are the long-term clinical implications of the two treatment methods?
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is at least 21 years old
- •The patient or legal representative provided written informed consent
- •The patient agrees to comply with the protocol-mandated follow-up visits and testing regime
- •The patient has lifestyle-limiting claudication or critical limb ischemia defined as: Fontaine stage IIa-IV/ Rutherford 1-5 category
- •The target lesion located within the popliteal artery has angiographic evidence of stenosis > 70% or occlusion (by visual estimate)
- •At least one vessel runoff to the foot
- •The patient has no other relevant inflow or outflow stenosis (> 50%), however when needed iliac or femoral intervention may be done during study procedure.
排除标准
- •The patient is currently participating in a drug or another device study.
- •The popliteal artery target lesion has previously been subintimal recanalized
- •The patient has a history of bleeding diatheses or coagulopathy
- •Female patients that are pregnant
- •The patient has a contraindication (including allergic reaction) to platelet aggregation inhibitors or heparin
- •The patient is unable to conform to the study protocol follow-up procedures or visits.
- •The patient has a life expectancy of <24 months
- •The patient has concomitant renal failure which requires dialysis
- •The patient has a contraindication (including allergic reaction) to or a known sensitivity to contrast media
- •The duplex ultrasound/angiography of the target lesion must NOT meet the following criteria:
- •The popliteal artery target lesion stenosis/occlusion is also continuously located within the superficial femoral artery and/or tibiofibular tract
- •The popliteal artery target lesion is restenotic
- •The popliteal artery has been subintimal recanalized
结局指标
主要结局
Restenosis rate (duplex ultrasound or angiographic stenosis >50% of vascular lumen diameter; PVR > 2.4 m/s)
时间窗: 12-month
次要结局
- Primary patency(12 and 24 months)
研究者
研究点 (4)
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