NCT01094678已完成不适用
Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 788
- 试验地点
- 8
- 主要终点
- Event-free Survival
研究概览
简要总结
The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.
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
- •stenosis of the above-the-knee femoropopliteal artery
- •appropriate size and location of the lesion
排除标准
- •pregnant or breast feeding
- •failure or inability to give informed consent
- •simultaneously participating in another drug or device study
结局指标
主要结局
Event-free Survival
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (8)
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