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 (ARCUS)

November 26, 2025 updated by: Endospan Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objective of the study is to collect and evaluate further early and long-term clinical safety and performance data of the NEXUS™ Aortic Arch Stent Graft System, for the treatment of thoracic aortic aneurysms involving the aortic arch, in the real-life standard of care setting, following CE mark approval in February 2019.

The NEXUS™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic diseases involving the aortic arch with proximal landing zone in ascending aorta and the Brachiocephalic artery. This includes:

  • Aneurysm
  • Dissecting aneurysm / dissection and intramural hematoma (IMH)
  • False / Pseudo aneurysm if not infected
  • Residual aneurysm/dissection following ascending aorta open repair
  • Penetrating ulcer, if not infected

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 hospitalisation following the index procedure (whichever occurs last), unless there is evidence of accidental or self-inflicted death.

Data from the initial hospitalisation through to discharge, including medical history, disease diagnostics, procedural information will be obtained to applicable standard-of-care of the participating centres. Furthermore, safety and performance data will be collected through to five years. Follow-up visits are expected at 30 days, 6 months, 12 months and annually through to five years

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc
        • Contact:
          • Arnaud Colle, Dr. med.
        • Principal Investigator:
          • Arnaud Colle, Dr. med.
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Hozan Mufty, Prof. Dr. med.
        • Principal Investigator:
          • Hozan Mufty, Prof. Dr. med.
  • Cyprus
    • Cyprus
      • Nicosia, Cyprus, Cyprus, 2024
        • Recruiting
        • Aretaieio Hospital
        • Contact:
          • Nikolaos Charalambous, Dr. med.
        • Principal Investigator:
          • Nikolaos Charalambous, Dr. med.
  • France
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Zakia IDIR
        • Principal Investigator:
          • Jean Marc ALSAC, M.D.
      • Paris, France
        • Recruiting
        • APHP Henri Mondor
        • Contact:
          • Pascal DESGRANGES
        • Principal Investigator:
          • Frédéric COCHENNEC
  • Germany
      • Berlin, Germany
        • Recruiting
        • German Heart Center
        • Contact:
        • Principal Investigator:
          • Semih Buz, M.D
      • Bonn, Germany
        • Recruiting
        • University Hospital Bonn
        • Contact:
          • Sonja Friese
        • Principal Investigator:
          • Farhad Bakthiary, Prof
    • Brandenburg
      • Bernau bei Berlin, Brandenburg, Germany, 16321
        • Recruiting
        • Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
        • Contact:
          • Michael Erb, Dr.med
        • Contact:
          • Julia Huebner, M.Sc
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • University Hospital Duesseldorf
        • Contact:
          • Britta Londong
        • Principal Investigator:
          • Markus Wagenhaeuser, MD
        • Sub-Investigator:
          • Hubert Schelzig, MD
  • Greece
      • Athens, Greece
        • Recruiting
        • Evaggelismos General Hospital
        • Contact:
          • Theodoros KRATIMENOS
        • Principal Investigator:
          • Theodoros KRATIMENOS, M.D.
  • Italy
      • Brescia, Italy, 25123
        • Not yet recruiting
        • Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
        • Contact:
          • Stefano Benussi, Prof. Dr. med.
        • Principal Investigator:
          • Stefano Benussi, Prof. Dr. med.
      • Padua, Italy
        • Recruiting
        • University Hospital Padoua
        • Contact:
        • Principal Investigator:
          • Augusto D'Onofrio, Prof
        • Sub-Investigator:
          • Michele Antonello, Prof
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Recruiting
        • Stichting Amsterdam UMC,
        • Contact:
          • Adrian, Hoksbergen
        • Contact:
          • Adrian Hoksbergen, Dr. med.
        • Principal Investigator:
          • Adrian Hoksbergen, Dr. med.
      • Groningen, Netherlands
        • Not yet recruiting
        • University Medical Center Groningen
        • Contact:
          • Jean-Paul de Vries, Prof. Dr. med.
        • Principal Investigator:
          • Jean-Paul de Vries, Prof. Dr. med.
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Medical University of Warsaw
        • Contact:
          • Magdalena Zurek
        • Principal Investigator:
          • Zbigniew Galazka, Prof
  • Spain
    • Andalusia
      • Cadiz, Andalusia, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
          • Miguel Gomez, MD
        • Principal Investigator:
          • Tomas Daroca, MD
        • Sub-Investigator:
          • Miguel Gomez, MD
    • Galicia
      • Vigo, Galicia, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro Vigo
        • Contact:
          • Beatriz Acuna Pais, MD
        • Principal Investigator:
          • Juan J Legarra, MD
        • Sub-Investigator:
          • Beatriz Acuna Pais
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
        • Contact:
          • Lyubov Chaykovska
        • Principal Investigator:
          • Mario Lachat, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
NEXUS Aortic Arch Stent Graft System
Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months
All-cause death events will be counted
12 months
Major Adverse Event (MAE)
Time Frame: 30 days and 12 months

Occurrence of at least one of the following MAEs at 30 days and 1 year post NEXUS implantation

  • Disabling Stroke
  • Permanent Paralysis/Paraplegia
  • Renal failure
  • Aortic rupture
  • Development of new dissections in the thoracic aorta or brachiocephalic artery
30 days and 12 months
Device failure
Time Frame: Procedure, 30 days, 12 months

Device Failure will be assessed via the following outcomes:

  • Peri-operative device failure
  • Device occlusion
  • Surgical conversion
  • Re-Intervention to treat migration,
  • Re-Intervention to treat stenosis or occlusion,
  • Re-Intervention to treat type Ia, Ib, III, IV endoleaks
  • Re-Intervention for loss of device integrity
Procedure, 30 days, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endospan Ltd.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CIP010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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