RecruitingNCT05636527

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


Sponsor

Endospan Ltd.

Enrollment

70 participants

Start Date

Nov 9, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with aat9. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05636527