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Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Sponsor: Artivion Inc.
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
Conditions
Interventions
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