NCT01558505已完成4 期
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
Leonardo Bolognese, MD1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2010年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- angiographic binary restenosis
研究概览
简要总结
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.
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
研究组 & 干预措施
standard PTA
Active Comparator
conventional balloon angioplasty
干预措施: POBA (Device)
Drug-eluting balloon angioplasty
Experimental
paclitaxel-eluting balloon angioplasty
干预措施: PEB (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
- major amputation(24 motnhs)
- target lesion revascularization(24 months)
- vessel reocclusion(24 months)
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato
研究点 (1)
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