Observational Study to Assess Safety and Performance of the NEXUS and Custom-Made NEXUS Multibranch Aortic Arch Stent Graft Systems for Aortic Aneurysm Treatment

What this Trial Is About

This observational study aims to collect clinical information on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO Aortic Arch Stent Graft System for treating aortic aneurysms. The main questions focus on early mortality, safety outcomes, device failure, and procedural and hospitalization details. Participants are treated according to standard care at their institutions. Participants receive treatment per their institutions standard of care using either the NEXUS Aortic Arch Stent Graft System or the custom-made NEXUS DUO Aortic Arch Stent Graft System. The study includes both prospective and retrospective data collection with two groups based on the device used. Follow-up information is collected for up to five years after treatment. During the study, researchers will gather data on mortality at 30 days and 12 months, major adverse events, device failure, and other safety outcomes. Participants will undergo regular follow-up visits to monitor these outcomes and collect hospitalization and procedural information. The study is designed to observe real-world use of these devices and understand their longer-term safety and performance.

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