NCT02648334已完成不适用
Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial
Seung-Whan Lee, M.D., Ph.D.28 个研究点 分布在 2 个国家目标入组 443 人开始时间: 2016年11月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 443
- 试验地点
- 28
- 主要终点
- the event rate of composite event
研究概览
简要总结
This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 and above
- •Subject with claudication or critical limb ischemia(Rutherford classification level 2~5)
- •Subject with total occlusion or stenosis ≥70%(de novo, restenosis)
- •Vessel diameter 4~6mm
- •Success to guide wire pass
- •Patients who don't have known hypersensitivity or allergy for dual-platelets
- •Willing and able to provide informed written consent
排除标准
- •Acute stage
- •Acute thrombosis in target limb or target vessel
- •Failure to guide wire pass
- •Distal outflow
- •Lesion with poor inflow
- •Life expectancy ≤ 2 years
- •Allergic to paclitaxel
- •Pregnant or breast feeding woman or disagree with contraception or having children
结局指标
主要结局
the event rate of composite event
时间窗: 1 year
all cause death, revascularization due to amputation or clinical evidence
次要结局
- target lesion revascularization(2 years)
- MACE(2 years)
- stroke(2 years)
- cardiac death(2 years)
- all cause death(2 years)
- myocardial infarction(2 years)
- amputation of target limb(2 years)
- The change of Rutherford classification(2 years)
- The change of ABI(ankle-brachial index) score(2 years)
- thrombosis(2 years)
研究者
Seung-Whan Lee, M.D., Ph.D.
Division of Cardiology
Asan Medical Center
研究点 (28)
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