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New stent system aims to tame dangerous aortic aneurysms

NCT ID NCT05636527

Disease control Sponsor: Endospan Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks 70 people receiving the NEXUS aortic arch stent graft, a device placed inside the aorta to treat aneurysms (bulging weak spots). Researchers will monitor safety, device failures, and survival for up to 5 years. The goal is to see how well the stent works in routine medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NEXUS aortic arch stent graft system (a device placed inside the aorta to reinforce a weakened area)
What this could lead to
If successful, this study could confirm that the NEXUS stent system is a safe and effective option for treating aortic arch aneurysms, potentially reducing the need for open-heart surgery.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include stroke, paralysis, kidney failure, or device failure, as noted in the outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic aneurysm aortic aneurysm, familial thoracic 9

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AAT9

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Henri Mondor

    RECRUITING

    Paris, France

  • Aretaieio Hospital

    RECRUITING

    Nicosia, Cyprus, 2024, Cyprus

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

    NOT_YET_RECRUITING

    Brescia, 25123, Italy

  • Cliniques universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Evaggelismos General Hospital

    RECRUITING

    Athens, Greece

  • German Heart Center

    RECRUITING

    Berlin, Germany

  • Hospital Alvaro Cunqueiro Vigo

    RECRUITING

    Vigo, Galicia, 36312, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, Andalusia, 11009, Spain

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • Immanuel Klinikum Brandenburg, Herzzentrum Brandenburg

    RECRUITING

    Bernau bei Berlin, Brandenburg, 16321, Germany

  • Klinikum Hirslanden, Aorten -und Gefäßzentrum, Zuerich

    RECRUITING

    Zurich, Switzerland

  • Medical University of Warsaw

    RECRUITING

    Warsaw, Poland

  • Stichting Amsterdam UMC,

    RECRUITING

    Amsterdam, 1081, Netherlands

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital Bonn

    RECRUITING

    Bonn, Germany

  • University Hospital Duesseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University Hospital Padoua

    RECRUITING

    Padova, Italy

  • University Medical Center Groningen

    NOT_YET_RECRUITING

    Groningen, Netherlands

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