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OpenTrials
Completed

NCT Number: NCT06187051

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

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.

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Key information

Conditions

Aorta Aneurysm Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1A endoleak after EVAR

Exclusion criteria

  • no

Treatment and study plan

FEVAR

Device

Relining the EVAR with FEVAR

Explantation

Device

open surgery to explant the previous EVAR

Primary outcomes

  1. Post operative mortality

    Time frame: day 30 post operative

    Patient death after the treatment of type 1A endoleak

  2. 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

  3. Redo surgery after type 1A endoleak surgery

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

    Reintervention after FEVAR or explantation surgery

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Paul Sabatier of Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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