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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04809896
Enrollment
200
Registered
2021-03-22
Start date
2020-01-01
Completion date
2021-05-01
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Arch Aneurysm

Keywords

Proximal descending aorta aneurism, Proximal and distal neck (length >20mm et diameter >20mm and <40mm, thoracic endovascular aortic repair, Intra-abdominal septic complications

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

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of retrograde aortic dissectionday 1Rate of retrograde aortic dissection

Secondary

MeasureTime frameDescription
Rate of endoleakday 1Rate of endoleak
Rate of strokeday 1Rate of stroke
Rate of Mortality30 daysMortality

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026