TRIOMPHE Study (Aortic Arch Disease)

Purpose of this Study

We are doing this to study to test how well an investigational technology called the Endospan NEXUS Aortic Arch Stent Graft System (the study device) performs in the treatment of aortic arch disease.

Who Can Participate?

Eligibility

Adults ages 18+ who are diagnosed with aortic arch disease and plan to have surgery. For more information about who can join this study, please contact the study team at susan.hajmohammad@duke.edu.

What is Involved?

Description

If you choose to join this study, you will:
  • Have your aorta repaired using the study device
  • Have 9 CT scans
  • Have 2 ultrasounds
  • Have neurological assessments
  • Fill out study questionnaires
  • Have check-ups with the study team for up to 5 years after your aortic repair surgery

Study Details

Full Title

A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS™ Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch

Principal Investigator

George
Hughes

Protocol Number

PRO00107432

NCT ID

NCT04471909

Phase

N/A

Enrollment Status

Open to Enrollment