临床试验/NCT01667393

NCT01667393撤回不适用

Popliteal Artery Trial of Patients Undergoing Treatment With Balloon Angioplasty vs. the Adaptive SUPERA VERITAS Peripheral Stent System

Abbott Medical Devices0 个研究点开始时间: 2013年1月最近更新: 2019年4月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 撤回
发起方: Abbott Medical Devices
主要终点: Primary patency

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.

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

•Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

排除标准

•Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

研究组 & 干预措施

IDEV SUPERA Stent

Experimental

Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.

干预措施: IDEV SUPERA Stent (Device)

Percutaneous Transluminal Angioplasty

Active Comparator

The target lesion will be treated by PTA alone.

干预措施: Percutaneous Transluminal Angioplasty (Device)

结局指标

主要结局

Primary patency

时间窗: 12 months

Primary efficacy will be target lesion primary patency at 12 months.

次要结局

MAE-free survival rate.(12 months)

研究者

发起方

Abbott Medical Devices

申办方类型

Industry

责任方

Sponsor

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