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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 1, 2021

Clinical Trial Outcome Measures

Primary Measures

  • Rate of retrograde aortic dissection
    • Time Frame: day 1
    • Rate of retrograde aortic dissection

Secondary Measures

  • Rate of endoleak
    • Time Frame: day 1
    • Rate of endoleak
  • Rate of stroke
    • Time Frame: day 1
    • Rate of stroke
  • Rate of Mortality
    • Time Frame: 30 days
    • Mortality

Participating in This Clinical Trial

Inclusion Criteria

  • patients operated on in our department between 2000 and January 2020 for a thoracic endoprosthesis Exclusion Criteria:

  • Patient who reject the study protocol

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ludovic CANAUD, Study Director, University Hospital, Montpellier

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