Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00615069
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2007-12-20
Brief Title:
Study of the Large Diameter GORE EXCLUDER AAA Endoprosthesis in Abdominal Aneurysms
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
A Clinical Study Evaluating the Use of the GORE EXCLUDER AAA Endoprosthesis - 31mm In the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2015-03
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 this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
Detailed Description:
The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms A secondary objective was to compare device performance of the original GORE EXCLUDER AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms
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