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RECRUITING
NCT04471909
NA

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Sponsor: Endospan Ltd.

View on ClinicalTrials.gov

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

DEVICE

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