Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03965364
Status:
WITHDRAWN
Last Update Posted:
2021-02-26
First Post:
2019-05-15
Brief Title:
China Post-market Study of the INCRAFT AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms INITIATION
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multicenter Open Label Prospective Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to lack of interest
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
INITIATION is a postmarket clinical follow-up study in China The purpose of the study is to continue to evaluate the safety and effectivenessperformance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice Approximately 120 subjects will be enrolled and followed through 1-years postprocedure Up to 20 sites in China may participate
Detailed Description:
INITIATION is a postmarket clinical follow-up study in China The purpose of the study is to continue to evaluate the safety and effectivenessperformance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice Approximately 120 subjects will be enrolled and followed through 1-years postprocedure Up to 20 sites in China may participate Subjects will be enrolled and followed at 1 month and 1 year post-procedure
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?:
True
Is an FDA AA801 Violation?:
None