Cure My Disease

Don't miss your cure!

 Log in / Sign up

10-Year study tracks new device for aortic repair

NCT ID NCT05639400

Disease control Sponsor: Vascutek Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study follows 352 adults with aortic arch or descending aorta disease who receive the Thoraflex Hybrid device, sometimes with an additional RelayPro stent-graft. The goal is to evaluate safety and treatment success over 10 years, including risks like stroke, spinal cord injury, and death. Participants receive standard care and are monitored for complications and device performance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

352 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Mar 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic aneurysm are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Dissection Dissection, Thoracic Aorta thoracic aortic aneurysm Thoracic Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm Aortic dissection Thoracic aortic aneurysm Thoracic aortic dissection Thoracic diseases

Contacts and locations

Locations

  • Ascension St. Vincent Heart Center

    Indianapolis, Indiana, 46290, United States

  • Baylor College of Medicine - St. Luke's

    Houston, Texas, 77030, United States

  • CHU Nantes

    Saint-Herblain, France

  • CHU de Toulouse - Hôpital de Rangueil

    Toulouse, 31059, France

  • Cedars-Sinai Medical Centre

    Los Angeles, California, 90048, United States

  • Duke University Medical Centre

    Durham, North Carolina, 27710, United States

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Hospital Clinic of Barcelona

    Barcelona, 08036, Spain

  • Keck Medical Centre of USC

    Los Angeles, California, 90089, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medstar Washington Hospital Centre

    Washington D.C., District of Columbia, 20010, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oxford University Hospitals NHS FT

    Oxford, OX3 9DU, United Kingdom

  • Paracelsus Medical University

    Salzburg, 5020, Austria

  • Policlinico Di S.Orsola, Universita' Di Bologna

    Bologna, 9 40138, Italy

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Dell Medical / Ascension Texas Cardiovascular

    Austin, Texas, 78705, United States

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8HW, United Kingdom

  • University of Alabama in Birmingham Medical Center

    Birmingham, Alabama, 35294, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Freiburg

    Freiburg im Breisgau, Germany

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Washington University/Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Weill Cornell medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.