NCT02840786已完成不适用
Occlusive Disease of Lower Extremity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- 12-month Primary Patency Rate
研究概览
简要总结
This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
详细描述
This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
12-month Primary Patency Rate
时间窗: 12 months
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
次要结局
- Technical success(1 day)
- freedom from clinically-driven TLR(12 months)
- Major Adverse Events at 12-month Post Procedure(12 months)
- 12-month Limb Salvage Rate(12 months)
研究者
研究点 (1)
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