EXTEND-001 Version 1.0
Research type
Research Study
Full title
Thoraflex Hybrid and Relay Extension Post-Approval Study.
IRAS ID
324779
Contact name
George Krasopoulos
Contact email
Sponsor organisation
Terumo Aortic
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 8 months, 1 days
Research summary
Terumo Aortic is a global medical device company dedicated to developing solutions for aortic and peripheral vascular disease.
The purpose of this study is to gather further information on the use of the Thoraflex Hybrid device alone and in combination with the RelayPro NBS Stent-graft; to treat aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Both devices received CE certification, demonstrating conformity to applicable EU requirements.
The Thoraflex Hybrid is intended for open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta. This study will enroll patients who require a Thoraflex Hybrid device and who may also have extensive pathology of the descending aorta requiring a RelayPro NBS stent-graft.
In patients who require a RelayPro NBS Stent-graft, this is known as an extension procedure.
The Thoraflex Hybrid device and RelayPro NBS Stent-graft may be placed during a single hospitalisation, or alternatively the Thoraflex Hybrid device may be placed during an initial hospitalisation and the RelayPro NBS Stent-graft placed at a later date. The time in-between these procedures could be short or long.
Only patients who receive a Thoraflex Hybrid device can participate in this study. The study will last for a total of 10 years from the point at which the Thoraflex Hybrid is placed.
Data will be collected prior to implantation of the Thoraflex Hybrid and RelayPro NBS stent-graft, at discharge or within 30 days of the implant of both devices, at 1 year after the implant of the Thoraflex Hybrid device, and then annually up to 10 years.
The data collected during this study may benefit doctors/surgeons and the Sponsor to gain a better understanding of how well the devices work over a longer period and how well the devices work together.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0337
Date of REC Opinion
29 May 2024
REC opinion
Further Information Favourable Opinion