Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04227054
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2020-01-10
Brief Title:
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
Sponsor:
Shape Memory Medical Inc
Organization:
Shape Memory Medical Inc
Study Overview
Official Title:
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
AAA-SHAPE
Brief Summary:
To determine the safety and efficacy of IMPEDE-FX Embolization Plug andor IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm AAA sac outside of an endovascular aneurysm repair EVAR stent graft
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None