Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01106391
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2010-04-16
Brief Title:
A Multicenter Open Label Prospective Non-Randomized Study Of INCRAFT In Subjects With AAA INNOVATION
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multicenter Open Label Prospective Non-Randomized Study Of INCRAFT In Subjects With Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2022-04
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:
INNOVATION
Brief Summary:
This study is a multi-center prospective open label non-randomized investigation of INCRAFT in subjects with abdominal aortic aneurysms
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy
The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy
Detailed Description:
This study is a multi-center prospective open label non-randomized investigation of INCRAFT in subjects with abdominal aortic aneurysms The study will enroll up to 60 subjects at 7 sites in Germany and Italy All treated subjects will be evaluated at 1 month 3 months if applicable 6 and 12 months and annually for a total of 5 years post-procedure An interim analysis will be conducted after the 25th enrolled subject reaches the 30-day follow up visit
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