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
NCT05636527 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70
Last updated 2025-12-04
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
Sponsors & Collaborators
-
Endospan Ltd.
lead INDUSTRY
Principal Investigators
-
Hubert Schelzig, MD · University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
-
Augusto D'Onofrio · Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-09
- Primary Completion
- 2027-03-31
- Completion
- 2030-07-31
Countries
- Belgium
- Cyprus
- France
- Germany
- Greece
- Italy
- Netherlands
- Poland
- Spain
- Switzerland
Study Locations
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