NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Inclusion Criteria:

1. Male and female age ≥ 18.

2. Proximal/ascending native or previously implanted surgical graft landing zone ofappropriate length

3. Proximal/ascending native or previously implanted surgical graft landing zone ofappropriate diameter

4. Distal/descending native landing zone of appropriate length

5. Distal/descending native landing zone of appropriate diameter

6. Brachiocephalic trunk native landing zone of appropriate length

7. Brachiocephalic trunk native landing zone of appropriate diameter

8. Appropriate take off angle between the Brachiocephalic Artery and the Aortic Archperpendicular

9. Appropriate aortic arch perpendicular diameter

10. Chronic dissection with at least one of the following conditions:

11. An aortic aneurysm with a maximum diameter ≥ 55 mm

12. Rapidly expanding false lumen (growth of > 0.5 cm/6 months)

13. Compressed true lumen associated with end organ malperfusion

14. Symptomatic

15. Aneurysm with at least one of the following conditions:

16. Dilatation of the aortic arch larger than 5 cm in diameter for subject withfusiform aneurysm

17. Dilatation of the aortic arch is 1.5 times the normal diameter for subjectsascending or descending

18. Dilation of the aortic arch larger than 2.5 cm for subject with saccularaneurysm

19. Symptomatic aneurysm of the aortic arch

20. Aortic diameter growth rate > 5mm per 6 months

21. Postoperative pseudoaneurysm expanding from anastomotic suture lines

22. Penetrating aortic ulcer with at least one of the following:

23. Symptomatic

24. Ulcer demonstrates expansion

25. Intramural hematoma with at least one of the following:

26. Symptomatic (persistent pain)

27. Transverse or longitudinal expansion on serial imaging

28. In the event of a lesion in the ascending aortic, the proximal/ascending native orpreviously implanted surgical graft the landing zone must be appropriate

29. Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascularaccess to the diseased site with a 20 Fr. delivery catheter.

30. Access vessels morphology suitable for endovascular repair in terms of tortuosity,calcification and angulation, documented by CTA/MRA.

31. Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.

32. Subject is considered an appropriate candidate for an elective surgery.

33. Subject is considered to be at high risk for open repair, as determined by theinvestigator.

34. Access vessels, iliac/femoral & brachial/axillary compatible with vascular accesstechniques (femoral cutdown or percutaneous), devices, and /or accessories.

35. Subject is willing and able to comply with procedures specified in the protocol andis able to return for follow-up visits as specified by the protocol.

Exclusion Criteria:

1. Acute dissection

2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSAvascularization)

3. Required emergent treatment, e.g., trauma, rupture

4. Acute vascular injury of the aorta due to trauma

5. Aortic rupture or unstable aneurysm

6. Received a previous stent or stent graft in the treated area (including plannedlanding area)

7. Required surgical or endovascular treatment of an infra-renal aneurysm at time ofimplantation

8. Planned major surgical or interventional procedure at time of screening, to beperformed after the NEXUS™ implantation.

9. Any major surgical or interventional procedure 6 weeks before the NEXUS™implantation, exclusive of planned procedures that are needed for the safe andeffective 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 bypain, 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 exposethe 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 intraluminalthrombus 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 (includingNitinol [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 ofdual antiplatelet or anticoagulant therapy by the decision of the investigator

29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine > 2.00mg/dl

30. Any other medical, social, or psychological issues that in the opinion of theinvestigator preclude them from receiving this treatment, or the procedures andevaluations pre- and post- treatment.

31. Active participation in another clinical study that has not completed primaryendpoint(s) evaluation or that clinically interferes with the endpoints in thisstudy, or subject is planning to participate in such study prior to the completionof this study.