Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

Inclusion Criteria10

• Male and female age ≥18 years
• The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
• The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
• The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
• The subject is able and willing to provide informed consent to participate in the study.
• Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
• In the opinion of the Investigator, life expectancy exceeds one year
• The subject is not pregnant or planning to become pregnant.
• In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
• In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days