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

Aortic Arch Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809896
• Other study ID #: RECHMPL21_0161
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Arch Aneurysm

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of retrograde aortic dissection	Rate of retrograde aortic dissection	day 1
Secondary	Rate of endoleak	Rate of endoleak	day 1
Secondary	Rate of stroke	Rate of stroke	day 1
Secondary	Rate of Mortality	Mortality	30 days