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NCT04809896
Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm
trial in Aortic Arch Aneurysm in 200 participants. Completed in 1 May 2021.
1 January 2021
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 January 2020 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 May 2021 |
| Sites | 1 location across France |
Conditions studied
- Aortic Arch Aneurysm — all drugs for Aortic Arch Aneurysm →
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.
Verify or expand the search:
- PubMed search for NCT04809896
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Arch Aneurysm
Currently open trials in the same condition.
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- NCT06520774 — Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases · NA · recruiting
- NCT05530304 — Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry. · recruiting
- NCT04765592 — Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Mo · NA · active not recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04809896 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 14 September 2021
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