NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Recruiting now · Not applicable

Conditions studied: Aortic Dissection, Aortic Aneurysm, Intramural Hematoma, Penetrating Aortic Ulcer

In brief

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.

Key facts

Study ID

NCT04471909

Run by

Endospan Ltd.

People needed

110

Starts

2020-10-20

Expected to finish

2029-10-01

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm
• Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending
• Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm
• Symptomatic aneurysm of the aortic arch
• Aortic diameter growth rate > 5mm per 6 months
• Postoperative pseudoaneurysm expanding from anastomotic suture lines
• Penetrating aortic ulcer with at least one of the following:
• Symptomatic
• Ulcer demonstrates expansion
• Intramural hematoma with at least one of the following:

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
• Life expectancy of less than 2 years
• Unsuitable vascular anatomy
• Subject who have a previously implanted surgical wrap of the ascending aorta
• Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure.
• An aneurysm that is mycotic, inflammatory or suspected to be infected.
• Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture) unless conduit are used.
• Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk
• Subject is suffering from unstable angina or NYHA classification III and IV.
• Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
• Subject with a contraindication to undergo angiography

Where it is running

• Auckland City Hospital — Auckland, Grafton, New Zealand (enrolling)
• University of California San Diego Medical Center — La Jolla, California, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor Scott and White — Plano, Texas, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
• Carilion Clinic — Roanoke, Virginia, United States (enrolling)
• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Stanford University School of Medicine — Stanford, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• MedStar Washington Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• The University of Chicago — Chicago, Illinois, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• The Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Northwell Health Lenox Hill Hospital — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• The Lindner Research Center — Cincinnati, Ohio, United States (enrolling)
• University Hospitals of Cleveland — Cleveland, Ohio, United States (enrolling)
• Oregon Health — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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