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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06187051
Enrollment
200
Registered
2024-01-02
Start date
2010-01-01
Completion date
2023-12-01
Last updated
2024-01-10

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

Conditions

Aorta Aneurysm

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.

Interventions

DEVICEFEVAR

Relining the EVAR with FEVAR

open surgery to explant the previous EVAR

Sponsors

University Paul Sabatier of Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Type 1A endoleak after EVAR

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Post operative mortalityday 30 post operativePatient death after the treatment of type 1A endoleak
Major adverse cardiovascular event (MACE) post operativeday 30 post operativePatient presenting after surgery a composite score (MACE) including * nonfatal stroke, * nonfatal myocardial infarction * cardiovascular death
Redo surgery after type 1A endoleak surgery30 day, 6 months, 12 months, 24 monthsReintervention after FEVAR or explantation surgery

Secondary

MeasureTime frameDescription
Efficiency of the treatment30 day, 6 months, 12 months, 24 monthsNo reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR

Outcome results

None listed

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