NCT01969630Unknown4 期
Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- angiographic binary restenosis
研究概览
简要总结
To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty
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 (Outcomes Assessor)
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
- •intermittent claudication or critical limb ischemia
- •de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
- •presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
- •presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)
排除标准
- •life expectancy <1 year
- •contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
- •need for major amputation (MA) at the time of enrolment
- •Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation
研究组 & 干预措施
PEB
Active Comparator
PEB angioplasty plus provisional nitinol stent implantation
干预措施: PEB (Device)
PES
Experimental
Systematic PES angioplasty
干预措施: PES (Device)
结局指标
主要结局
angiographic binary restenosis
时间窗: 12 months
incidence of binary restenosis
次要结局
- Composite of all cause mortality, major amputation and target lesion revascularization.(12 months)
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato
研究点 (1)
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