Thoraflex Hybrid and Relay Extension Post-Approval Study

Running, not enrolling

Conditions studied: Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection

In brief

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

Key facts

Study ID

NCT05639400

Run by

Vascutek Ltd.

People needed

352

Starts

2023-03-17

Expected to finish

2036-03-01

Last updated by the study team

2026-02-06

Who can join

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

You may qualify if…

• Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.
• Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

You may not qualify if…

• Patient has any medical, social, or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure.

Where it is running

• University of Alabama in Birmingham Medical Center — Birmingham, Alabama, United States
• Cedars-Sinai Medical Centre — Los Angeles, California, United States
• Keck Medical Centre of USC — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Medstar Washington Hospital Centre — Washington D.C., District of Columbia, United States
• Northwestern University — Chicago, Illinois, United States
• Ascension St. Vincent Heart Center — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
• Weill Cornell medicine — New York, New York, United States
• Duke University Medical Centre — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UPMC Presbyterian — Pittsburgh, Pennsylvania, United States
• UT Dell Medical / Ascension Texas Cardiovascular — Austin, Texas, United States
• Baylor College of Medicine - St. Luke's — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Paracelsus Medical University — Salzburg, Austria
• CHU Nantes — Saint-Herblain, France
• CHU de Toulouse - Hôpital de Rangueil — Toulouse, France
• University of Freiburg — Freiburg im Breisgau, Germany
• Policlinico Di S.Orsola, Universita' Di Bologna — Bologna, Italy
• Hospital Clinic of Barcelona — Barcelona, Spain
• University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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