TRIOMPHE Study (Aortic Arch Disease) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Aortic Arch Disease

Who Can Participate in the Study?

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.

Age Group
Adults

What is Involved?

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
Heart Surgeon
Protocol Number
IRB: PRO00107432
NCT: NCT04471909
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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