Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029660
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-09-01
Brief Title:
AAA-SHAPE Pivotal Trial Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Sponsor:
Shape Memory Medical Inc
Organization:
Shape Memory Medical Inc
Study Overview
Official Title:
AAA-SHAPE Pivotal Trial Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair EVAR stent graft treatment in trial subjects considered candidates for elective EVAR
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?:
None
Is an FDA AA801 Violation?:
None