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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04809896
Other study ID # RECHMPL21_0161
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 1, 2021

Study information

Verified date September 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of retrograde aortic dissection Rate of retrograde aortic dissection day 1
Secondary Rate of endoleak Rate of endoleak day 1
Secondary Rate of stroke Rate of stroke day 1
Secondary Rate of Mortality Mortality 30 days
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