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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
Sponsor: Endospan Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2022-11-09
Completion Date
2030-07
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Locations (18)
Cliniques universitaires Saint Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Aretaieio Hospital
Nicosia, Cyprus, Cyprus
APHP Henri Mondor
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
German Heart Center
Berlin, Germany
University Hospital Bonn
Bonn, Germany
Evaggelismos General Hospital
Athens, Greece
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Brescia, Italy
University Hospital Padoua
Padova, Italy
Stichting Amsterdam UMC,
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Medical University of Warsaw
Warsaw, Poland
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, Spain
Hospital Alvaro Cunqueiro Vigo
Vigo, Galicia, Spain
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
Zurich, Switzerland