跳至主要内容
临床试验/NCT03996889
NCT03996889Unknown不适用

Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Major limb events

研究概览

简要总结

This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years old at time of treatment
  • symptomatic or asymptomatic popliteal artery aneurysm needing surgery
  • scheduled elective surgery

排除标准

  • life expectancy of <1 year
  • thrombotic occlusion of popliteal artery
  • intolerance to antiplatelet drugs (antiaggregants)
  • known allergies to GORE VIABAHN® stent graft materials/composition
  • emergency surgery

结局指标

主要结局

Major limb events

时间窗: 2 years of follow-up

Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation. An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected: * Permeability * Intra-stent restenosis * Systolic pressure index

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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