NCT01556542已完成4 期
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Leonardo Bolognese, MD2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2010年11月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- angiographic binary restenosis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
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
- Double (Participant, 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
- •age>18 years
- •intermittent claudication(Fontane III or IV)
- •angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm
- •at least one below-knee vessel to the ankle
排除标准
- •allergy to Paclitaxel
- •contraindication for combined antiplatelet treatment
- •life expectancy <1 year
- •hypersensitivity or contraindication to one of the study drugs
- •lack of consent
结局指标
主要结局
angiographic binary restenosis
时间窗: 12 months
incidence of binary restenosis
次要结局
- major amputation(24 months)
- target lesion revascularization(24 months)
- vessel reocclusion(24 months)
研究者
Leonardo Bolognese, MD
Director of Cardiovascular Department
Ospedale San Donato
研究点 (2)
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