Terumo Aortic Global Endovascular Registry

Recruiting now

Conditions studied: Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery

In brief

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Key facts

Study ID

NCT04246463

Run by

Vascutek Ltd.

People needed

1000

Starts

2019-12-17

Expected to finish

2030-11-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum age as per local regulations
• Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft
• Ability to provide informed consent
• o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR).
• Willingness to comply with the registry protocol
• Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.

You may not qualify if…

• Patient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.

Where it is running

• Long Beach Memorial Medical Center — Long Beach, California, United States (enrolling)
• UC Health Memorial Hospital Center — Colorado Springs, Colorado, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Loyola University of Chicago (Loyola) — Chicago, Illinois, United States (enrolling)
• Ascension St. Vincent Heart Center — Indianapolis, Indiana, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Ascension Texas Cardiovascular / UT Dell Medical School — Austin, Texas, United States (enrolling)
• Baylor, Scott & White Health (BSW Health) — Texas City, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Virgina — Charlottesville, Virginia, United States (enrolling)
• Sentara Heart Hospital — Norfolk, Virginia, United States (enrolling)
• Imeldaziekenhuis — Bonheiden, Belgium (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Hôpital Pneumologique et Cardiovasculaire Louis-Pradel — Bron, France (enrolling)
• CHU St Etienne — Saint-Etienne, France (enrolling)
• Klinikum Augsburg — Augsburg, Germany (enrolling)
• Evangelisches Krankenhaus Hubertus — Berlin, Germany (enrolling)
• Klinikum Chemnitz — Chemnitz, Germany (enrolling)
• University Heart Center Freiburg — Freiburg im Breisgau, Germany (enrolling)
• Bonifatius Hospital — Lingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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