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NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Sponsor: Endospan Ltd.
Summary
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
Official title: A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2020-10-20
Completion Date
2029-10
Last Updated
2025-10-20
Healthy Volunteers
No
Interventions
NEXUS Aortic Stent Graft System
Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta. Ascending Stent Graft intended to be deployed in the Ascending Aorta. OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
Locations (32)
University of Alabama Birmingham
Birmingham, Alabama, United States
University of California San Diego Medical Center
La Jolla, California, United States
UC Davis Health
Sacramento, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, United States
Advent Health Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Ascension St. Vincent
Carmel, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Mount Sinai Medical Center
New York, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Research Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Oregon Health
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ballad Health
Kingsport, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott and White
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
Auckland City Hospital
Auckland, Grafton, New Zealand