NCT05636527

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

A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study With Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• AAT9

Timeline

• Start date: 2022-11-09
• Primary completion: 2027-03-01
• Completion: 2030-07-01
• First posted: 2022-12-05
• Last updated: 2025-12-04

Locations

18 sites across 10 countries: Belgium, Cyprus, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland