RecruitingNot ApplicableNCT04471909

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

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


Sponsor

Endospan Ltd.

Enrollment

110 participants

Start Date

Oct 20, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The NEXUS trial evaluates a new endovascular stent graft designed to treat complex diseases of the aortic arch — the curved section of the large artery that carries blood from the heart. Conditions like aortic aneurysms, dissections, and intramural hematomas affecting the arch are among the most challenging in cardiovascular surgery. This minimally invasive approach aims to treat these conditions through catheters in the groin rather than open chest surgery, reducing recovery time and surgical risk. You may be eligible if... - You are 18 years or older - You have a significant aortic arch condition (aneurysm, chronic dissection, penetrating ulcer, or intramural hematoma) with specific anatomical criteria - You are considered high-risk for open surgical repair - You are willing to attend follow-up imaging and clinic visits You may NOT be eligible if... - You have an acute (emergency) aortic dissection or rupture - You have had a heart attack or stroke within the past 90 days - You have a connective tissue disorder like Marfan syndrome - You are pregnant - You have severe kidney failure or an active systemic infection - You have a known allergy to the implant materials (Nitinol, polyester, tantalum) Talk to your vascular or cardiothoracic surgeon if you have been diagnosed with an aortic arch condition. This study offers access to a novel minimally invasive approach for conditions that are otherwise very high-risk to treat.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENEXUS 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

View Full Details on ClinicalTrials.gov

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NCT04471909


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