Active, not recruitingNo phase
Thoraflex Hybrid and Relay Extension Post-Approval Study
Key facts
- Who runs it
- Vascutek Ltd.
- Where
- Aurora, Austin, Baltimore, Birmingham, Boston, Chicago, Durham, Hartford, Houston, Indianapolis, Los Angeles, New York, Philadelphia, Pittsburgh, Salt Lake City, St Louis, and Washington D.C., United StatesSee the 18 sitesAlso in 6 other countries, 9 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 352 people enrolled
- Started
- 17 Mar 2023
- Expected to end
- Mar 2036
- Type of study
- Observational
- Treatments tested
- Thoraflex Hybrid
- RelayPro NBS
- Record updated
- 6 February 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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 in United States
Also in 6 other countries, 9 sites
- University of ColoradoAurora, United StatesNo longer taking part
- UT Dell Medical / Ascension Texas CardiovascularAustin, United StatesNo longer taking part
- University of MarylandBaltimore, United StatesNo longer taking part
- University of Alabama in Birmingham Medical CenterBirmingham, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Duke University Medical CentreDurham, United StatesNo longer taking part
- Hartford HospitalHartford, United StatesNo longer taking part
- Baylor College of Medicine - St. Luke'sHouston, United StatesNo longer taking part
- Ascension St. Vincent Heart CenterIndianapolis, United StatesNo longer taking part
- Cedars-Sinai Medical CentreLos Angeles, United StatesNo longer taking part
- Keck Medical Centre of USCLos Angeles, United StatesNo longer taking part
- Weill Cornell MedicineNew York, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- UPMC PresbyterianPittsburgh, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
- Washington University (Barnes-Jewish Hospital)St Louis, United StatesNo longer taking part
- Medstar Washington Hospital CentreWashington D.C., United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
Treatments tested
- Thoraflex Hybrid
- RelayPro NBS
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 February 2026