Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578741
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to confirm that the benefit-risk assessment of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis TAMBE Device remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program
Detailed Description:
A maximum of 300 adult subjects will be enrolled at up to 60 US centers with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device Subjects will have follow-up at 1 month 6 months 12 months and annually thereafter through 10 years post implant
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