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

Completed

• Conditions: Aortic Arch Aneurysm

• Registration Number: NCT04809896
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Completion: 2021-05-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient who reject the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of retrograde aortic dissection	day 1	Rate of retrograde aortic dissection

Secondary Outcome Measures

Name	Time	Method
Rate of stroke	day 1	Rate of stroke
Rate of endoleak	day 1	Rate of endoleak
Rate of Mortality	30 days	Mortality

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France