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

ConditionAAT9
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEndospan Ltd.

About this trial

The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.

The main question\[s\] it aims to answer are:

* Early mortality * Safety outcomes throughout the study * Device failure throughout the study * Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

70 Participants
are grouped into 2 trial groups

Sponsors and collaborators