Purpose of this Study
We are dong this study to collect information about the use of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device). The TAMBE Device was approved by the FDA in 2024 for use in endovascular repair as a treatment for patients with thoracoabdominal and pararenal aortic aneurysms. We want to get data about how well the device performs in the patients who choose to get this implant.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have aortic disease in need of endovascular repair
- Plan to get the Gore TAMBE device for treatment
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, we will schedule you for follow-up visits following your procedure to implant the Gore TAMBE device. These visits will include physical exams, blood draws, CT scans, and neurological testing. The visits will happen according to the following schedule:
- 1 month after your procedure
- 6 months after your procedure
- Once per year for 10 years after the second visit
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Principal Investigator
George
Hughes
Protocol Number
PRO00116971
NCT ID
NCT06578741
Phase
N/A
Enrollment Status
Pending Open to Enrollment