Thoraflex Hybrid and Relay Extension Post-Approval Study

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.

Conditions

Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection

Study Overview

Study Details

Study overview

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.

Thoraflex Hybrid and Relay Extension Post-Approval Study

Thoraflex Hybrid and Relay Extension Post-Approval Study

Condition
Thoracic Diseases
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama in Birmingham Medical Center, Birmingham, Alabama, United States, 35294

Los Angeles

Cedars-Sinai Medical Centre, Los Angeles, California, United States, 90048

Los Angeles

Keck Medical Centre of USC, Los Angeles, California, United States, 90089

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06106

Washington

Medstar Washington Hospital Centre, Washington, District of Columbia, United States, 20010

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University/Barnes Jewish Hospital, Saint Louis, Missouri, United States, 63110

New York

Weill Cornell medicine, New York, New York, United States, 10065

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vascutek Ltd.,

Martin Czerny, PRINCIPAL_INVESTIGATOR, University of Freiburg

Joseph E Bavaria, PRINCIPAL_INVESTIGATOR, Jefferson Health and Sidney Kimmel Medical College

Study Record Dates

2036-12