Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586021
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Evaluation of the Aortoseal for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SEAL - Safety Feasibility Evaluation of the Aortoseal for Seal and Fixation of Abdominal Aortic Aneurysms AAA Endovascular Grafts to the Aortic Wall
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Aortoseal Endostapling System is indicated in patients undergoing or having undergone treatment of an abdominal aortic aneurysm AAA with an endovascular graft to provide enhanced fixation and apposition to the aorta
Detailed Description:
The device may be implanted at the time of the initial endovascular graft procedure to maintain or during a secondary procedure to restore adequate aneurysm
The study includes 5 years of follow-up with visits at 30 days 6 months 1 year and yearly thereafter through 5-years
Follow-up assessments Physical examination X-ray CT with and without contrast and assessments of any adverse events
The study includes 5 years of follow-up with visits at 30 days 6 months 1 year and yearly thereafter through 5-years
Follow-up assessments Physical examination X-ray CT with and without contrast and assessments of any adverse events
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