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
NCT ID: NCT05636527
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2022-11-09
2030-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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NEXUS Aortic Arch Stent Graft System
No interventions assigned to this group
Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
5. The subject is able and willing to provide informed consent to participate in the study.
6. Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
7. In the opinion of the Investigator, life expectancy exceeds one year
8. The subject is not pregnant or planning to become pregnant.
9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
10. In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days
18 Years
ALL
No
Sponsors
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Endospan Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hubert Schelzig, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery
Augusto D'Onofrio
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua
Locations
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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
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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Arnaud Colle, Dr. med.
Role: primary
Hozan Mufty, Prof. Dr. med.
Role: primary
Nikolaos Charalambous, Dr. med.
Role: primary
Pascal DESGRANGES
Role: primary
Zakia IDIR
Role: primary
Michael Erb, Dr.med
Role: primary
Julia Huebner, M.Sc
Role: backup
Britta Londong
Role: primary
Sonja Friese
Role: primary
Theodoros KRATIMENOS
Role: primary
Stefano Benussi, Prof. Dr. med.
Role: primary
Adrian, Hoksbergen
Role: primary
Adrian Hoksbergen, Dr. med.
Role: backup
Jean-Paul de Vries, Prof. Dr. med.
Role: primary
Magdalena Zurek
Role: primary
Miguel Gomez, MD
Role: primary
Beatriz Acuna Pais, MD
Role: primary
Lyubov Chaykovska
Role: primary
Other Identifiers
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CIP010
Identifier Type: -
Identifier Source: org_study_id
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