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RECRUITING
NCT07089576
NA

Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Sponsor: Artivion Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.

Official title: A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-11-04

Completion Date

2032-07

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DEVICE

Arcevo™ LSA Hybrid Stent Graft System

The Arcevo LSA Hybrid Stent Graft System is an implantable aortic stent graft with LSA branch which is preloaded onto a delivery system and implanted during an open surgical procedure, or more specifically a total arch replacement procedure. The device is intended for use with a proximal surgical graft (not supplied). If additional coverage is needed, a protocol specified thoracic endovascular aortic repair (TEVAR) device may be used.

Locations (10)

University of Southern California

Los Angeles, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Texas - Austin

Austin, Texas, United States

Baylor Scott & White

Plano, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States