Clinical Trial

Thoraflex Hybrid and Relay Extension Post-Approval Study

Study acronym: EXTEND
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-12-05; most recent amendment 2026-02-03.
Status change: Recruiting → Active, Not Recruiting 2026-02-03
Status change: Not Yet Recruiting → Recruiting 2023-06-19
Trial Details
NCT Number NCT05639400
Lead Sponsor Vascutek Ltd.
Collaborators: Bolton Medical
Conditions Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
Enrollment 352 participants
Start Date 2023-03-17
Primary Completion 2035-07 (estimated)
Study Completion 2036-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-06