ARISE II (Ascending Aorta Repair)

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 susan.hajmohammad@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