Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT02777593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
SSB 11-02
Brief Summary:
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
Detailed Description:
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.
Study Oversight
Has Oversight DMC:
True
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?: