NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

NCT04471909 | Recruiting DMC FDA Device

• 1 other identifier: CIP-009
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 32

Brief 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.

Conditions

Aortic Dissection; Aortic Aneurysm; Intramural Hematoma; Penetrating Aortic Ulcer

Outcome Measures

Primary Outcomes (2)

• Device Technical Failure

  * Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures * Device occlusion * Failed exclusion of primary entry tear * Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.

  30 Days

• Clinical Failure

  Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.

  30 Days

Study Arms (3)

Chronic Dissection (arm closed to enrollment)

EXPERIMENTAL

Device: NEXUS Aortic Stent Graft System

Penetrating Aortic Ulcer and/or Intramural Hematoma

EXPERIMENTAL

Device: NEXUS Aortic Stent Graft System

Aneurysm (arm closed to enrollment)

EXPERIMENTAL

Device: NEXUS Aortic Stent Graft System

Interventions

NEXUS Aortic Stent Graft System DEVICE

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.

Aneurysm (arm closed to enrollment); Chronic Dissection (arm closed to enrollment); Penetrating Aortic Ulcer and/or Intramural Hematoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female age ≥ 18.
• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
• Distal/descending native landing zone of appropriate length
• Distal/descending native landing zone of appropriate diameter
• Brachiocephalic trunk native landing zone of appropriate length
• Brachiocephalic trunk native landing zone of appropriate diameter
• Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular
• Appropriate aortic arch perpendicular diameter
• Chronic dissection with at least one of the following conditions:
• An aortic aneurysm with a maximum diameter ≥ 55 mm
• Rapidly expanding false lumen (growth of \> 0.5 cm/6 months)
• Compressed true lumen associated with end organ malperfusion
• Symptomatic
• Aneurysm with at least one of the following conditions:

You may not qualify if:

• Acute dissection
• Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)
• Required emergent treatment, e.g., trauma, rupture
• Acute vascular injury of the aorta due to trauma
• Aortic rupture or unstable aneurysm
• Received a previous stent or stent graft in the treated area (including planned landing area)
• Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation
• Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation.
• Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass).
• Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation
• Subjects with severe aortic valvular insufficiency as determined by echocardiography
• Mechanical valve that preclude safe delivery of NEXUS™
• Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)
• Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture
• Pregnant

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (32)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of California San Diego Medical Center

La Jolla, California, 92037, United States

RECRUITING

UC Davis Health

Sacramento, California, 95817, United States

COMPLETED

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32804, United States

COMPLETED

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Ascension St. Vincent

Carmel, Indiana, 46290, United States

COMPLETED

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

COMPLETED

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

The Mount Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Northwell Health Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Atrium Health

Charlotte, North Carolina, 28203, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

COMPLETED

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Oregon Health

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

COMPLETED

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Ballad Health

Kingsport, Tennessee, 37660, United States

COMPLETED

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor Scott and White

Plano, Texas, 75093, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Aortic Aneurysm; Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Jessica Kleine

CONTACT

+1 (612) 280-0208; j.kleine@endospan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: October 20, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

NZ (1); US (31)