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

NCT ID: NCT04809896

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-05-01

Brief Summary

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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

Detailed Description

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Conditions

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Aortic Arch Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ludovic CANAUD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL21_0161

Identifier Type: -

Identifier Source: org_study_id

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