NEXUS™ Aortic Arch Stent Graft System First In Man Study

Exclusion Criteria

• •Female is of childbearing potential
• •Life expectancy of less than 1 year
• •Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
• •Acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta.
• •Patient with an increased risk for aneurysm rupture during the procedure.
• •Patient whose arterial access site is not anticipated to accommodate the access of the Nexus™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture)
• •Patients with severe atherosclerosis or intraluminal thrombus of the aorta or in the BCT
• •Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
• •Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation
• •Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
• •Patient with a contraindication to undergo angiography
• •Patient with known sensitivities or allergies to the device materials- Nitinol and polyester
• •Clinical conditions that severely inhibit x-ray visualization of the Aorta.
• •Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)
• •Patient has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator
• •Patient has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture and/or leukocytosis (WBC \> 11,000 mm3).
• •Patients who have the condition that threatens to infect the stent graft.
• •Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \> 2.00 mg/dl or \> 182 umol/L
• •Patient underwent major surgery or interventional procedure in the last three months.
• •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 trial that is reasonable to conflict with the NexusTM study.