Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best

Aorta Aneurysm Clinical Trial

Official title:

FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187051
• Other study ID #: Type 1 endoleak : FEVAR vs OSR
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: University Paul Sabatier of Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.

A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type 1A endoleak after EVAR

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Aneurysm
• Aorta Aneurysm
• Aortic Aneurysm
• Endoleak

Intervention

Device:
• FEVAR
Relining the EVAR with FEVAR
• Explantation
open surgery to explant the previous EVAR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Paul Sabatier of Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative mortality	Patient death after the treatment of type 1A endoleak	day 30 post operative
Primary	Major adverse cardiovascular event (MACE) post operative	Patient presenting after surgery a composite score (MACE) including; nonfatal stroke,; nonfatal myocardial infarction; cardiovascular death	day 30 post operative
Primary	Redo surgery after type 1A endoleak surgery	Reintervention after FEVAR or explantation surgery	30 day, 6 months, 12 months, 24 months
Secondary	Efficiency of the treatment	No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR	30 day, 6 months, 12 months, 24 months