Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 8:02 AM
Study NCT ID:
NCT02816333
Status:
WITHDRAWN
Last Update Posted:
2018-06-21
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the withdrawal of Gore Korea Co.Ltd., manufacturer of medical device, it is impossible to supply the medical device(C-TAG).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.
Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.
Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: