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ACTIVE NOT RECRUITING
NCT03214601
NA

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

Sponsor: Bolton Medical

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.

Official title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2017-12-04

Completion Date

2028-08-31

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

DEVICE

penetrating atherosclerotic ulcer, aorta branch cardiovascular implant

The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.

Locations (12)

University of Southern California

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Barnes Jewish Hospital at Washington University

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania/Penn Presbyterian

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Baylor Scott and White Research Institute

Plano, Texas, United States