Clinical trialNCT05639400Active, not recruitingObservational

Thoraflex Hybrid and Relay Extension Post-Approval Study

SponsorVascutek Ltd.Enrollment352Aortic AneurysmAortic DissectionThoracic Aortic AneurysmThoracic Aortic DissectionThoracic Diseases

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Joseph E Bavaria
Jefferson Health and Sidney Kimmel Medical College
Principal Investigator
clinicaltrials.gov ↗
Martin Czerny
University of Freiburg
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria

Paracelsus Medical University
Salzburg, Austria

France

Chu Nantes
Saint-Herblain, France
Chu de Toulouse - Hôpital de Rangueil
Toulouse, France

Germany

University of Freiburg
Freiburg im Breisgau, Germany

Italy

Policlinico Di S.Orsola, Universita' Di Bologna
Bologna, Italy

Spain

Hospital Clinic of Barcelona
Barcelona, Spain

United Kingdom

University Hospitals Bristol and Weston Nhs Foundation Trust
Bristol, United Kingdom
Oxford University Hospitals Nhs Ft
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Mar 2023
Primary completion: 31 Jul 2035
Completion: 31 Mar 2036
Last update posted: 6 Feb 2026
Registered enrollment: 352
Registry id: NCT05639400

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.