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NCT04809896

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

Completed Last updated 14 September 2021
What this trial tests

trial in Aortic Arch Aneurysm in 200 participants. Completed in 1 May 2021.

Timeline
1 January 2020
Primary endpoint
1 January 2021
1 May 2021

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment200
Start date1 January 2020
Primary completion1 January 2021
Estimated completion1 May 2021
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Eligibility, any sex, with Aortic Arch Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Aortic Arch Aneurysm

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04809896.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing