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 | Recruiting

• 1 other identifier: CIP010
• Study Type: observational
• Target: 70
• Locations: 10 countries
• Sites: 18

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mortality

  The primary outcome in this study is early mortality, defined as lesion related death or any death that occurs within 30-days post-procedure or within initial hospitalization following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death

  30 days

Secondary Outcomes (3)

• Mortality

  12 months

• Major Adverse Event (MAE)

  30 days and 12 months

• Device failure

  Procedure, 30 days, 12 months

Study Arms (2)

NEXUS Aortic Arch Stent Graft System

Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a thoracic aortic aneurysm or chronic dissection extending to or involving the aortic arch and who are considered candidates for the endovascular repair.

1. Male and female age ≥18 years 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (18)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Aretaieio Hospital

Nicosia, Cyprus, 2024, Cyprus

RECRUITING

APHP Henri Mondor

Paris, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, France

RECRUITING

Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg

Bernau bei Berlin, Brandenburg, 16321, Germany

RECRUITING

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

German Heart Center

Berlin, Germany

RECRUITING

University Hospital Bonn

Bonn, Germany

RECRUITING

Evaggelismos General Hospital

Athens, Greece

RECRUITING

Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

University Hospital Padoua

Padua, Italy

RECRUITING

Stichting Amsterdam UMC,

Amsterdam, 1081, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

NOT YET RECRUITING

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Andalusia, 11009, Spain

RECRUITING

Hospital Alvaro Cunqueiro Vigo

Vigo, Galicia, 36312, Spain

RECRUITING

Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich

Zurich, Switzerland

RECRUITING

Study Officials

• Hubert Schelzig, MD

  University Hospital Duesseldorf, University Clinic for Vascular and Endovascular Surgery

  PRINCIPAL INVESTIGATOR

• Augusto D'Onofrio

  Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natali Yosef

CONTACT

+972507599447; natali@endospan.com

Jessica Kleine

CONTACT

+16122800208; j.kleine@endospan.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 5, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

GR (1); NL (2); DE (4); CY (1); BE (2); PL (1); FR (2); IT (2); ES (2); CH (1)