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RECRUITING
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

Sponsor: Endospan Ltd.

View on ClinicalTrials.gov

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