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

Completed

• Conditions: Aorta Aneurysm
• Interventions: Device: Explantation; Device: FEVAR

• Registration Number: NCT06187051
• Lead Sponsor: University Paul Sabatier of Toulouse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-29
• Status Verified: 2024-01
• Study First Posted: 2024-01-02
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

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

Inclusion Criteria

• Type 1A endoleak after EVAR

Exclusion Criteria

• no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR	Explantation	-
Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR	FEVAR	-

Primary Outcome Measures

Name	Time	Method
Redo surgery after type 1A endoleak surgery	30 day, 6 months, 12 months, 24 months	Reintervention after FEVAR or explantation surgery
Major adverse cardiovascular event (MACE) post operative	day 30 post operative	Patient presenting after surgery a composite score (MACE) including; * nonfatal stroke,; * nonfatal myocardial infarction; * cardiovascular death
Post operative mortality	day 30 post operative	Patient death after the treatment of type 1A endoleak

Secondary Outcome Measures

Name	Time	Method
Efficiency of the treatment	30 day, 6 months, 12 months, 24 months	No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR