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

January 8, 2024 updated by: Aurélien Hostalrich, University Paul Sabatier of Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

  • Type 1A endoleak after EVAR

Exclusion Criteria:

  • no

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR
Device: FEVAR
Relining the EVAR with FEVAR
Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR
Device: Explantation
open surgery to explant the previous EVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative mortality
Time Frame: day 30 post operative
Patient death after the treatment of type 1A endoleak
day 30 post operative
Major adverse cardiovascular event (MACE) post operative
Time Frame: day 30 post operative

Patient presenting after surgery a composite score (MACE) including

  • nonfatal stroke,
  • nonfatal myocardial infarction
  • cardiovascular death
day 30 post operative
Redo surgery after type 1A endoleak surgery
Time Frame: 30 day, 6 months, 12 months, 24 months
Reintervention after FEVAR or explantation surgery
30 day, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency of the treatment
Time Frame: 30 day, 6 months, 12 months, 24 months
No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR
30 day, 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paul Sabatier of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Type 1 endoleak : FEVAR vs OSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aorta Aneurysm

Clinical Trials on FEVAR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe