AAT9ARCUSNCT05636527
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
An observational study of AAT9, run by Endospan Ltd. at 18 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AAT9
- How many people
- 70 participants
- Where
- 18 sitesin 10 countries
- Study dates
- 9 Nov 2022to Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- Male and female age ≥18 years
- The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or
- The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or
- The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU
- The subject is able and willing to provide informed consent to participate in the study.
- 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.
- In the opinion of the Investigator, life expectancy exceeds one year
- The subject is not pregnant or planning to become pregnant.
- In the physician's opinion, subject's renal function is stable for the NEXUS procedure.
- 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
Trial locations and contacts
18 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 10 countries
Germany4 sites, 4 recruiting
- Recruiting
German Heart Center
Berlin
Ursi WACKER, herzchirugie@dhzb.de
Semih Buz, M.D
- Recruiting
Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, 16321
Michael Erb, Dr.med
Julia Huebner, M.Sc
- Recruiting
University Hospital Bonn
Bonn
Sonja Friese
Farhad Bakthiary, Prof
- Recruiting
University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Britta Londong
Markus Wagenhaeuser, MD
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques universitaires Saint Luc
Brussels, 1200
Arnaud Colle, Dr. med.
Arnaud Colle, Dr. med.
- Recruiting
UZ Leuven
Leuven, 3000
Hozan Mufty, Prof. Dr. med.
Hozan Mufty, Prof. Dr. med.
France2 sites, 2 recruiting
- Recruiting
APHP Henri Mondor
Paris
Pascal DESGRANGES
Frédéric COCHENNEC
- Recruiting
Hôpital Européen Georges Pompidou
Paris
Zakia IDIR
Jean Marc ALSAC, M.D.
Italy2 sites, 2 recruiting
- Not yet recruiting
Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia
Brescia, 25123
Stefano Benussi, Prof. Dr. med.
Stefano Benussi, Prof. Dr. med.
- Recruiting
University Hospital Padoua
Padova
Giorgia Cibin, cibin.gio@gmail.com
Augusto D'Onofrio, Prof
Netherlands2 sites, 2 recruiting
- Recruiting
Stichting Amsterdam UMC,
Amsterdam, 1081
Adrian, Hoksbergen
Adrian Hoksbergen, Dr. med.
- Not yet recruiting
University Medical Center Groningen
Groningen
Jean-Paul de Vries, Prof. Dr. med.
Jean-Paul de Vries, Prof. Dr. med.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, 11009
Miguel Gomez, MD
Tomas Daroca, MD
- Recruiting
Hospital Alvaro Cunqueiro Vigo
Vigo, Galicia, 36312
Beatriz Acuna Pais, MD
Juan J Legarra, MD
Cyprus1 site, 1 recruiting
- Recruiting
Aretaieio Hospital
Nicosia, Cyprus, 2024
Nikolaos Charalambous, Dr. med.
Nikolaos Charalambous, Dr. med.
Greece1 site, 1 recruiting
- Recruiting
Evaggelismos General Hospital
Athens
Theodoros KRATIMENOS
Theodoros KRATIMENOS, M.D.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw
Magdalena Zurek
Zbigniew Galazka, Prof
Switzerland1 site, 1 recruiting
- Recruiting
Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich
Zurich
Lyubov Chaykovska
Mario Lachat, M.D.
About this study
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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NEXUS Aortic Arch Stent Graft System | Not described | |
| Custom-made NEXUS Multibranch™ Aortic Arch Stent Graft System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (3)
Mortality
All-cause death events will be counted
Measured: 12 months
Major Adverse Event (MAE)
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
Measured: 30 days and 12 months
Device failure
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
Measured: Procedure, 30 days, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start9 Nov 2022
- Primary completionMar 2027 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAT9Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Schelzig, MD, Principal investigator, University Hospital Duesseldorf, University Clinic for Vascular and Endovascular SurgeryAugusto D'Onofrio, Principal investigator, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636527
- Sponsor's protocol ID
- CIP010
- Acronym
- ARCUS
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No