What is the Purpose of this Study?
The purpose of this study is to gather further information on the standard-of-care use of a device called the Thoraflex Hybrid alone and in combination with the RelayPro NBS Stent-Graft to treat aortic disease. The Thoraflex Hybrid Device is intended for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta, with or without involvement of the ascending aorta, in cases of aneurysm and/or dissection. Participants in this study require treatment of damaged or diseased vessels of the aortic arch and descending aorta (with or without involvement of the ascending aorta) and have been chosen to receive treatment for their condition using the Thoraflex Hybrid device, as well as possibly the RelayPro NBS stent graft. The U.S. Food and Drug Administration (FDA) has approved the Thoraflex Hybrid device as it is being used in this study. Researchers will gather outcome information from patients about their treatment with a Thoraflex Hybrid Device and RelayPro NBS Stent-graft (if required).
Eligibility
- Patient is aged 18 years or older on date of consent. Patient is willing and able to comply with all study procedures and visits. Patient or their next of kin (NOK)/legally designated representative (LDR) has given written informed consent to participate in the study.
- 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Thoraflex Hybrid and Relay Extension Post-Approval Study