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CompletedNCT06187051Updated Jan 10, 2024

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

An observational study in Aorta Aneurysm, sponsored by University Paul Sabatier of Toulouse. Completed. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by University Paul Sabatier of Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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.

02

Conditions studied

  • Aorta Aneurysm
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient presenting a type 1A endoleak after EVAR for AAA during the follow up

Inclusion criteria

  • Type 1A endoleak after EVAR

Exclusion criteria

Exclusion Criteria:

  • no
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR

    Device: FEVAR

  • Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR

    Device: Explantation

Interventions

  • DeviceFEVAR

    Relining the EVAR with FEVAR

  • DeviceExplantation

    open surgery to explant the previous EVAR

05

What researchers measure

Primary outcomes

  1. Post operative mortality

    Patient death after the treatment of type 1A endoleak

    Time frame: day 30 post operative

  2. Major adverse cardiovascular event (MACE) post operative

    Patient presenting after surgery a composite score (MACE) including * nonfatal stroke, * nonfatal myocardial infarction * cardiovascular death

    Time frame: day 30 post operative

  3. Redo surgery after type 1A endoleak surgery

    Reintervention after FEVAR or explantation surgery

    Time frame: 30 day, 6 months, 12 months, 24 months

Secondary outcomes

  1. Efficiency of the treatment

    No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR

    Time frame: 30 day, 6 months, 12 months, 24 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06187051
Lead sponsor
University Paul Sabatier of Toulouse
Responsible party
Aurélien Hostalrich (Clinical Professor, University Paul Sabatier of Toulouse) — Principal investigator
First posted
Jan 2, 2024
Start date
Jan 1, 2010
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Jan 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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