Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-29 @ 2:16 AM
Study NCT ID:
NCT00874250
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2009-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Sponsor:
W.L.Gore & Associates
Organization:
Study Overview
Official Title:
An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
Status:
COMPLETED
Status Verified Date:
2017-07
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:
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
\> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
\> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
Detailed Description:
None
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?: