Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02528500
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2015-08-17
Brief Title:
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Early Feasibility Assessment of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
Status:
COMPLETED
Status Verified Date:
2023-06
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:
This study will assess the initial feasibility of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis TAMBE Device in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels
Detailed Description:
This is a prospective non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels A maximum of 10 Subjects will be treated under this Protocol This clinical study will include up to six sites in the US Each enrolled subject will undergo periodic follow-up evaluations involving physical exams contrast-enhanced computed tomography CT of chest abdomen and pelvis creatinine measurement abdominal ultrasound optional at specific protocol-defined intervals for a period of five years following the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis 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