Viewing Study NCT06578741



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