Purpose of this Study
In this study, people will have a device called the Gore TAMBE placed in their body. After the device is placed, doctors will check on them at about one month, six months, and then once each year for ten years. At these visits, people will have a physical exam, blood tests, CT scans, and tests to check how their brain and nerves are working.
Who Can Participate?
Eligibility
Adults with aortic disease in need of endovascular repair
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
This study is being done to collect information about a medical device called the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis, also known as the TAMBE Device. This device is already approved for use by the FDA. It is used to help doctors fix large weak areas in the main blood vessel, called aneurysms, near or involving the kidneys and other major organs. The study will help doctors learn more about how the device works in patients.
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
Open to Enrollment