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临床试验/NCT04809896
NCT04809896已完成不适用

Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Rate of retrograde aortic dissection

研究概览

简要总结

The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair.

The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient who reject the study protocol

结局指标

主要结局

Rate of retrograde aortic dissection

时间窗: day 1

Rate of retrograde aortic dissection

次要结局

  • Rate of stroke(day 1)
  • Rate of endoleak(day 1)
  • Rate of Mortality(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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