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
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.
• Male and female age ≥ 18.
• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
• Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
• Distal/descending native landing zone of appropriate length
• Distal/descending native landing zone of appropriate diameter
• Brachiocephalic trunk native landing zone of appropriate length
• Brachiocephalic trunk native landing zone of appropriate diameter
• Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular
• Appropriate aortic arch perpendicular diameter
⁃ Chronic dissection with at least one of the following conditions:
∙ An aortic aneurysm with a maximum diameter ≥ 55 mm
‣ Rapidly expanding false lumen (growth of \> 0.5 cm/6 months)
‣ Compressed true lumen associated with end organ malperfusion
‣ Symptomatic
⁃ Aneurysm with at least one of the following conditions:
∙ Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm
‣ Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending
‣ Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm
‣ Symptomatic aneurysm of the aortic arch
‣ Aortic diameter growth rate \> 5mm per 6 months
‣ Postoperative pseudoaneurysm expanding from anastomotic suture lines
⁃ Penetrating aortic ulcer with at least one of the following:
∙ Symptomatic
‣ Ulcer demonstrates expansion
⁃ Intramural hematoma with at least one of the following:
∙ Symptomatic (persistent pain)
‣ Transverse or longitudinal expansion on serial imaging
⁃ 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
⁃ Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.
⁃ Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA.
⁃ Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.
⁃ Subject is considered an appropriate candidate for an elective surgery.
⁃ Subject is considered to be at high risk for open repair, as determined by the investigator.
⁃ Access vessels, iliac/femoral \& brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.
⁃ 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.