临床试验/NCT01057316

NCT01057316已完成不适用

Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis

Cook Group Incorporated21 个研究点分布在 4 个国家目标入组 120 人开始时间: 2010年2月最近更新: 2018年6月1日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Cook Group Incorporated
入组人数: 120
试验地点: 21
主要终点: Percent Diameter Stenosis of the Treated Renal Artery

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研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

•renal artery stenosis
•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

研究组 & 干预措施

Study Group A

Experimental

干预措施: Formula PTX Stent - Dose 1 (Device)

Study Group B

Experimental

干预措施: Formula PTX Stent - Dose 2 (Device)

Study Group C

Experimental

干预措施: Formula PTX Stent - Dose 3 (Device)

结局指标

主要结局

Percent Diameter Stenosis of the Treated Renal Artery

时间窗: 9 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 (21)

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