NCT01348425已完成不适用
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- Percent Change in Stent Length Upon Deployment
研究概览
简要总结
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal 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
- •One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
- •Reference vessel diameter of 4 - 9 mm
- •Rutherford category ≥ 2
- •Resting ankle brachial index < 0.9
排除标准
- •Prior stent in the study vessel
- •Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
- •Lacks at least one patent runoff vessel
- •Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
结局指标
主要结局
Percent Change in Stent Length Upon Deployment
时间窗: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
次要结局
未报告次要终点
研究者
研究点 (8)
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