Purpose of this Study
In this study, people will be treated with the Gore TBE device as part of their regular surgery planned by their doctor. The study will collect information from normal follow up visits for up to ten years. Participants will also be asked to fill out a questionnaire before surgery and again at each follow up visit to help doctors understand how they are doing over time.
Who Can Participate?
Eligibility
This study is for adults who have a problem with the main blood vessel in the chest, called the thoracic aorta. These adults are planning to be treated with a medical device called the Gore TBE device as part of their care.
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
The purpose of this study is to collect information about how well a medical device called the Gore TAG Thoracic Branch Endoprosthesis works. Doctors will also look at how patients do over a long period of time after receiving the device. This information will help doctors understand the safety and long term results of using this device.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
GORE TAG Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Principal Investigator
George
Hughes
Protocol Number
PRO00119673
NCT ID
NCT07166133
Phase
N/A
Enrollment Status
Pending Open to Enrollment