跳至主要内容
临床试验/NCT01609621
NCT01609621已完成不适用

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

Cook Group Incorporated11 个研究点 分布在 3 个国家目标入组 199 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
11
主要终点
Technical Success deeming tibial pedal arterial access

研究概览

简要总结

The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. For institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required.

排除标准

  • Patient will not sign the Informed Consent

结局指标

主要结局

Technical Success deeming tibial pedal arterial access

时间窗: 1 - 4 hours post-procedure.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

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