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).
10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA)
within 90 days prior to the planned implantation
11. Subjects with severe aortic valvular insufficiency as determined by echocardiography 12. Mechanical valve that preclude safe delivery of NEXUS™ 13. Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes) 14. Subject has an active systemic infection at the time of the procedure documented by
pain, fever, drainage, positive culture
15. Pregnant 16. Life expectancy of less than 2 years 17. Unsuitable vascular anatomy 18. Subject who have a previously implanted surgical wrap of the ascending aorta 19. Any medical condition that, according to the investigator's decision, might expose the
subject to increased risk by the investigational device or procedure.
20. An aneurysm that is mycotic, inflammatory or suspected to be infected. 21. Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture)
unless conduit are used.
22. Subjects with severe atherosclerosis, severe calcification or extensive intraluminal
thrombus of the aorta or in the brachiocephalic trunk
23. Subject is suffering from unstable angina or NYHA classification III and IV. 24. Subject has a known hypersensitivity or contraindication to anticoagulants,
antiplatelets, or contrast media, which is not amenable to pre-treatment.
25. Subject with a contraindication to undergo angiography 26. Subject with known sensitivities or allergies to the device materials (including
Nitinol [NiTi], polyester fabric [PET], tantalum [TA])
27. Clinical conditions that severely inhibit x-ray visualization of the Aorta. 28. 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
29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine > 2.00
mg/dl
30. 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.
31. 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.