NCT06187051

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

13.9 years

First QC Date

December 15, 2023

Last Update Submit

January 8, 2024

Conditions

Aorta Aneurysm

Outcome Measures

Primary Outcomes (3)

  • Post operative mortality

    Patient death after the treatment of type 1A endoleak

    day 30 post operative

  • 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

  • Redo surgery after type 1A endoleak surgery

    Reintervention after FEVAR or explantation surgery

    30 day, 6 months, 12 months, 24 months

Secondary Outcomes (1)

  • Efficiency of the treatment

    30 day, 6 months, 12 months, 24 months

Study Arms (2)

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

FEVARDEVICE

Relining the EVAR with FEVAR

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

open surgery to explant the previous EVAR

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Type 1A endoleak after EVAR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Endovascular Aneurysm RepairDevice Removal

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 2, 2024

Study Start

January 1, 2010

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01