NCT01938872Unknown不适用
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- angiographic binary restenosis
研究概览
简要总结
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
angiographic binary restenosis
时间窗: 12 months
incidence of binary restenosis
次要结局
未报告次要终点
研究者
Leonardo Bolognese, MD
Director
Ospedale San Donato
研究点 (1)
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