Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02308839
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2014-11-21
Brief Title:
GORE EXCLUDER Endoprosthesis French Mandatory Registry
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Study of the GORE EXCLUDER Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None