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Thoraflex Hybrid and Relay Extension Post-Approval Study
Sponsor: Vascutek Ltd.
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
352
Start Date
2023-03-17
Completion Date
2036-03
Last Updated
2026-02-06
Healthy Volunteers
Not specified
Conditions
Interventions
Thoraflex Hybrid
Thoraflex Hybrid is designed for the open surgical repair of aneurysms and/or dissections in the aortic arch and descending aorta with or without involvement of the ascending aorta. There are two types of Thoraflex Hybrid implants, namely the Plexus 4 and the Ante-Flo versions. Each patient receives one Thoraflex Hybrid device (either the Plexus 4 or Ante-Flo).
RelayPro NBS
The RelayPro NBS Thoracic Stent-Graft System is an endovascular device intended for treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma.
Locations (27)
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
Oxford University Hospitals NHS FT
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom