NCT02279784Unknown4 期
Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- number of events of angiographic binary restenosis
研究概览
简要总结
The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.
详细描述
Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).
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
- •angiographic stenosis>50% or occlusion of one below-knee vessel
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
- •need for amputation
结局指标
主要结局
number of events of angiographic binary restenosis
时间窗: 12 months
number of events of angiographic binary restenosis
次要结局
- frequency of major amputation(12 months)
- number of events of target lesion revascularization(12 months)
- number of events of death(12 months)
研究者
Leonardo Bolognese, MD
MD
Ospedale San Donato
研究点 (2)
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