Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05442489
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2024-05-30
First Post:
2022-02-21
Brief Title:
Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms TAMBE
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Evaluation of the GORE EXCLUDER Thoracoabdominal BranchTreatment of the Thoracoabdominal and Pararenal Aortic Aneurysms TAMBE
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2024-10
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:
TAMBE
Brief Summary:
Expanded access tothe GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms
Detailed Description:
Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious but non-life-threatening condition In the requesting physicians opinion there must be no acceptable alternative treatment option Patients are to be consented with an Emergency Compassionate Use ICF template provided by Gore upon request for this type of device use Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject Upon performance of the case the site will immediately notify Gore and provide supporting documentation to facilitate timely compliant regulatory reporting
Study Oversight
Has Oversight DMC:
None
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?:
None