Clinical Trial

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

Study acronym: RelayBranch
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2017-07-10; most recent amendment 2025-05-28.
Status change: Recruiting → Active, Not Recruiting 2023-11-10
Status change: Not Yet Recruiting → Recruiting 2017-12-18
Trial Details
NCT Number NCT03214601
Lead Sponsor Bolton Medical
Conditions Thoracic Aorta Aneurysm, Aneurysm, Ruptured, Aortic Aneurysm
Enrollment 30 participants
Start Date 2017-12-04
Primary Completion 2023-09-18 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-31