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

NCT04809896 | Completed

• 1 other identifier: RECHMPL21_0161
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Rate of retrograde aortic dissection

  Rate of retrograde aortic dissection

  day 1

Secondary Outcomes (3)

• Rate of endoleak

  day 1

• Rate of stroke

  day 1

• Rate of Mortality

  30 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population requiring this procedure is elderly, with major comorbidities and some of these indications are given in an emergency context.

You may qualify if:

• \- patients operated on in our department between 2000 and January 2020 for a thoracic endoprosthesis

You may not qualify if:

• \- Patient who reject the study protocol

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• ludovic CANAUD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

FR (1)