Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01379222
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2011-06-21
Brief Title:
Endurant Stent Graft System Post Approval Study ENGAGE PAS
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System ENGAGE PAS
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:
None
Brief Summary:
The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment through the endpoints established in this protocol
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality ARM
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality ARM
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?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None