NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Exclusion Criteria31

• 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
• Subject with known sensitivities or allergies to the device materials (including Nitinol \[NiTi\], polyester fabric \[PET\], tantalum \[TA\])
• Clinical conditions that severely inhibit x-ray visualization of the Aorta.
• Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator
• Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \> 2.00 mg/dl
• Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
• Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this study.