Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03728985
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2018-09-28
Brief Title:
Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05442489
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
TAMBE
Brief Summary:
Prospective non-randomized multicenter study with two independent arms
Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System Hypothesis-driven analysis
Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only
Secondary Study Arm - TAAA requiring TAMBE System and CTAG Devices Non hypothesis-driven analysis
Minimum 122 implanted subjects Maximum 202 implanted subjects with up to 65 additional subjects implanted in Continued Access Primary Study arm
Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System Hypothesis-driven analysis
Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only
Secondary Study Arm - TAAA requiring TAMBE System and CTAG Devices Non hypothesis-driven analysis
Minimum 122 implanted subjects Maximum 202 implanted subjects with up to 65 additional subjects implanted in Continued Access Primary Study arm
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None