NCT01901289已完成不适用
Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 32
- 主要终点
- Patients Without Target Lesion Revascularization (TLR)
研究概览
简要总结
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
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 signed and dated the informed consent.
- •Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
- •Patient agrees to return for the required follow-up assessments.
排除标准
- •Patient is < 18 years of age.
- •Patient has significant stenosis of inflow tract not successfully treated before this procedure.
- •Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
结局指标
主要结局
Patients Without Target Lesion Revascularization (TLR)
时间窗: 1 year
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
次要结局
未报告次要终点
研究者
研究点 (32)
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