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NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Trial ID: NCT04471909
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.
A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch
1. Male and female age ≥ 18.
2. Proximal/ascending native or previously implanted surgical graft landing zone of
3. Proximal/ascending native or previously implanted surgical graft landing zone of
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 Arch
9. Appropriate aortic arch perpendicular diameter
10. Chronic dissection with at least one of the following conditions:
1. An aortic aneurysm with a maximum diameter ≥ 55 mm
2. Rapidly expanding false lumen (growth of > 0.5 cm/6 months)
3. Compressed true lumen associated with end organ malperfusion
11. Aneurysm with at least one of the following conditions:
1. Dilatation of the aortic arch larger than 5 cm in diameter for subject with
2. Dilatation of the aortic arch is 1.5 times the normal diameter for subjects
ascending or descending
3. Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm
4. Symptomatic aneurysm of the aortic arch
5. Aortic diameter growth rate > 5mm per 6 months
6. Postoperative pseudoaneurysm expanding from anastomotic suture lines
12. Penetrating aortic ulcer with at least one of the following:
2. Ulcer demonstrates expansion
13. Intramural hematoma with at least one of the following:
1. Symptomatic (persistent pain)
2. Transverse or longitudinal expansion on serial imaging
14. In the event of a lesion in the ascending aortic, the proximal/ascending native or
previously implanted surgical graft the landing zone must be appropriate
15. Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular
access to the diseased site with a 20 Fr. delivery catheter.
16. Access vessels morphology suitable for endovascular repair in terms of tortuosity,
calcification and angulation, documented by CTA/MRA.
17. Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.
18. Subject is considered an appropriate candidate for an elective surgery.
19. Subject is considered to be at high risk for open repair, as determined by the
20. Access vessels, iliac/femoral & brachial/axillary compatible with vascular access
techniques (femoral cutdown or percutaneous), devices, and /or accessories.
21. Subject is willing and able to comply with procedures specified in the protocol and is
able to return for follow-up visits as specified by the protocol.
1. Acute dissection
2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA
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 planned
7. Required surgical or endovascular treatment of an infra-renal aneurysm at time of
8. Planned major surgical or interventional procedure at time of screening, to be
performed 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 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
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
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
device: NEXUS Aortic Stent Graft System