GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

W.L. Gore & Associates

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: GORE® EXCLUDER® Endoprosthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT02308839

FPR12-02

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design