Brief Title
GORE® EXCLUDER® Endoprosthesis French Mandatory Registry
Official Title
Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Brief Summary
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).
Detailed 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.
Study Type
Observational [Patient Registry]
Primary Outcome
Percentage of Participants Survived at 5 Years
Secondary Outcome
Percentage of Participants Free From Endoleak at 5 Years
Condition
Abdominal Aortic Aneurysm
Intervention
GORE® EXCLUDER® Endoprosthesis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
181
Start Date
July 2012
Completion Date
October 5, 2018
Primary Completion Date
September 26, 2018
Eligibility Criteria
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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eric Steinmetz, Prof, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02308839
Organization ID
FPR12-02
Responsible Party
Sponsor
Study Sponsor
W.L.Gore & Associates
Study Sponsor
Eric Steinmetz, Prof, Principal Investigator, Centre Hospitalier Universitaire du Bocage
Verification Date
May 2020