RECRUITING

Thoraflex Hybrid and Relay Extension Post-Approval Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Thoraflex Hybrid and Relay Extension Post-Approval Study

Quick Facts

Study Start:2023-03-17
Study Completion:2036-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05639400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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.

Contacts and Locations

Study Contact

Donna McDougall
CONTACT
+441418125555
d.mcdougall@terumoaortic.com
Michelle Durnan
CONTACT
+441418125555
m.durnan@terumoaortic.com

Principal Investigator

Martin Czerny
PRINCIPAL_INVESTIGATOR
University of Freiburg
Joseph E Bavaria
PRINCIPAL_INVESTIGATOR
Jefferson Health and Sidney Kimmel Medical College

Study Locations (Sites)

University of Alabama in Birmingham Medical Center
Birmingham, Alabama, 35294
United States
Cedars-Sinai Medical Centre
Los Angeles, California, 90048
United States
Keck Medical Centre of USC
Los Angeles, California, 90089
United States
University of Colorado
Aurora, Colorado, 80045
United States
Hartford Hospital
Hartford, Connecticut, 06106
United States
Medstar Washington Hospital Centre
Washington, District of Columbia, 20010
United States
Northwestern University
Chicago, Illinois, 60611
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University/Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States
Weill Cornell medicine
New York, New York, 10065
United States
Duke University Medical Centre
Durham, North Carolina, 27710
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
United States
Baylor College of Medicine - St. Luke's
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Vascutek Ltd.

  • Martin Czerny, PRINCIPAL_INVESTIGATOR, University of Freiburg
  • Joseph E Bavaria, PRINCIPAL_INVESTIGATOR, Jefferson Health and Sidney Kimmel Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-17
Study Completion Date2036-12

Study Record Updates

Study Start Date2023-03-17
Study Completion Date2036-12

Terms related to this study

Keywords Provided by Researchers

  • TEVAR
  • Frozen Elephant Trunk (FET)

Additional Relevant MeSH Terms

  • Thoracic Diseases
  • Aortic Aneurysm
  • Aortic Dissection
  • Thoracic Aortic Aneurysm
  • Thoracic Aortic Dissection