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Evaluating the Thoraflex Hybrid device for aortic diseases

Thoraflex Hybrid and Relay Extension Post-Approval Study

Observational Vascutek Ltd. · NCT05639400

This study is testing how well the Thoraflex Hybrid device, alone and with another stent-graft, can help adults with aortic diseases affecting the aortic arch and descending aorta over a 10-year period.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorVascutek Ltd. Industry-sponsored
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT05639400 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of the Thoraflex Hybrid device, both alone and in combination with the RelayPro NBS stent-graft, in treating aortic diseases affecting the aortic arch and descending aorta. Patients aged 18 and older who receive this treatment will be enrolled and monitored over a 10-year period, following standard care protocols at participating sites. The study will gather data on patient outcomes to evaluate the long-term performance of these devices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require treatment for thoracic aortic diseases and are willing to comply with study procedures.

Not a fit: Patients with medical, social, or psychological issues that prevent them from undergoing the treatment or participating in the study will not benefit.

Why it matters

Potential benefit: If successful, this study could improve treatment options and outcomes for patients with complex aortic diseases.

How similar studies have performed: While this approach is being evaluated in this study, similar devices have shown promise in previous studies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thoracic DiseasesAortic AneurysmAortic DissectionThoracic Aortic AneurysmThoracic Aortic DissectionTEVARFrozen Elephant Trunk
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.