Thoraflex Hybrid and Relay Extension Post-Approval Study
NCT ID: NCT05639400
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
352 participants
OBSERVATIONAL
2023-03-17
2036-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Bolton Medical
INDUSTRY
Vascutek Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Czerny
Role: PRINCIPAL_INVESTIGATOR
University of Freiburg
Joseph E Bavaria
Role: PRINCIPAL_INVESTIGATOR
Jefferson Health and Sidney Kimmel Medical College
Locations
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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
Countries
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Other Identifiers
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EXTEND-001
Identifier Type: -
Identifier Source: org_study_id
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