Purpose of this Study
We are doing this study to determine the safety and effectiveness of an experimental medical device called the GORE Ascending Stent Graft (ASG Device) for the treatment of aortic diseases.
Who Can Participate?
Eligibility
Adults ages 18+ who plan to have surgical repair made to their ascending aorta.
For more information about who can join this study, contact the study team at dana.giangiacomo@duke.edu.
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 agree to be in this study, you will:
- Have your aorta repaired with the GORE Ascending Stent Graft (ASG Device)
- Have neurological assessments
- Have CT scans
- Fill out questionnaires
- Give the study team permission to collect information from your medical record
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta (ARISE II)
Principal Investigator
George
Hughes
Protocol Number
PRO00113653
NCT ID
NCT05800743
Phase
N/A
Enrollment Status
Open to Enrollment