Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444821
Status:
TERMINATED
Last Update Posted:
2021-10-11
First Post:
2007-03-06
Brief Title:
The PIVOTAL Study
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
Positive Impact of Endovascular Options for Treating Aneurysms Early PIVOTAL
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis of Primary Endpoint completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms AAA4-5CM with respect to AAA rupture and AAA related deaths
Detailed Description:
None
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