Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT00507559
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2007-07-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Pivotal Study of the Aptus Endovascular AAA Repair System
Sponsor:
Medtronic Cardiovascular
Organization:
Study Overview
Official Title:
The Pivotal Study of the Aptus Endovascular AAA Repair System
Status:
COMPLETED
Status Verified Date:
2021-10
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:
STAPLE-2
Brief Summary:
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
Detailed Description:
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
Study Oversight
Has Oversight DMC:
True
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?: