Purpose of this Study
Participants will undergo physical exams, blood tests, CT angiograms, and a procedure to place a study stent device. After the procedure, they will have follow up visits over 5 years and complete questionnaires so researchers can monitor their health and the performance of the device.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults age 22 or older who need a procedure to restore blood flow in the iliac arteries and whose doctor determines that the procedure can be performed using the study stent device.
Age Range
22-110
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 testing a new stent device called the GORE® EXCLUDER® IBE Plus Stent Graft for people with aneurysms in the abdominal aorta or common iliac arteries. Researchers want to learn how safe the device is and how well it works to treat these blood vessel conditions.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
Principal Investigator
Chandler
Long
Protocol Number
PRO00120452
NCT ID
NCT07304102
Phase
N/A
Enrollment Status
Pending Open to Enrollment