Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04809896
Collaborator
(none)
200
Enrollment
1
Location
16
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Jan 1, 2021
    Actual Study Completion Date :
    May 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Rate of retrograde aortic dissection [day 1]

      Rate of retrograde aortic dissection

    Secondary Outcome Measures

    1. Rate of endoleak [day 1]

      Rate of endoleak

    2. Rate of stroke [day 1]

      Rate of stroke

    3. Rate of Mortality [30 days]

      Mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: ludovic CANAUD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04809896
    Other Study ID Numbers:
    • RECHMPL21_0161
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Proximal descending aorta aneurism
    Proximal and distal neck (length >20mm et diameter >20mm and <40mm
    thoracic endovascular aortic repair
    Intra-abdominal septic complications
    Additional relevant MeSH terms:
    Aneurysm

    Study Results

    No Results Posted as of Sep 14, 2021