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NCT Number: NCT02308839

GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Dijon

Dijon, 21034, France

About this study

The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Exclusion criteria

  • Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).

Treatment and study plan

GORE® EXCLUDER® Endoprosthesis

Device

Endovascular therapy to treat abdominal aortic aneurysms

Primary outcomes

  1. Percentage of Participants Survived at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant survival at 5 years

Secondary outcomes

  1. Percentage of Participants Free From Endoleak at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years

  2. Percentage of Participants Free From Migration at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant freedom from migration at 5 years

  3. Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years

  4. Percentage of Participants Free From Aneurysm Related Mortality at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years

  5. Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years

    Time frame: 5 years

    Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years

  6. Percentage of Participants Free From Surgical Conversion at Procedure

    Time frame: Index Procedure

    Participant freedom from surgical conversion at procedure

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2014
Registry last updated
May 22, 2020

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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