NCT02271529已完成不适用
Zilver Paclitaxel(PTX) Thumbwheel Delivery System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Mean Percent Change in Stent Length Upon Deployment
研究概览
简要总结
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
- •Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
排除标准
- •Patient is < 18 years of age
- •Patient unable to complete required follow-up assessments
- •Patient unwilling to sign and date the informed consent
- •Simultaneous participation in another investigational drug or device study
- •Pregnant, breastfeeding or planning to become pregnant in the next 5 years
- •Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan
结局指标
主要结局
Mean Percent Change in Stent Length Upon Deployment
时间窗: Immediately following completion of the stent placement procedure
次要结局
未报告次要终点
研究者
研究点 (12)
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