Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 5:50 AM
Study NCT ID:
NCT07166133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.
Detailed Description:
Minimum of 125 total subjects with a TBE Device implantation procedure initiated in up to 50 Sites in the United States. Subjects will have follow-up at 1 Month, 6 Month, 1 Year, and annually thereafter for a minimum of 5-years and up to a maximum of 10 years.
Study Oversight
Has Oversight DMC:
False
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?: