临床试验/NCT02171962

NCT02171962已完成不适用

Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

Cook Group Incorporated15 个研究点分布在 1 个国家目标入组 178 人开始时间: 2014年6月最近更新: 2017年3月22日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cook Group Incorporated
入组人数: 178
试验地点: 15
主要终点: Primary Patency as Assessed by Duplex Ultrasonography

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

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

•Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
•Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
•Reference vessel diameter of 4-9 mm
•Lesion length up to 140 mm

排除标准

•Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
•Previous stent in the study vessel
•Bypass graft with an anastomosis in the study vessel
•Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
•No patent vessel of runoff

结局指标

主要结局

Primary Patency as Assessed by Duplex Ultrasonography

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方

Cook Group Incorporated

申办方类型

Industry

责任方

Sponsor

研究点 (15)

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