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New stent aims to seal brain aneurysms safely

NCT ID NCT05543447

Disease control Sponsor: Acandis GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a device called DERIVO 2heal, a small mesh tube placed in an artery to block blood flow into a brain aneurysm. The goal is to see if it safely and effectively seals the aneurysm over the medium and long term. About 158 adults with brain aneurysms will be enrolled, and researchers will track outcomes like complete aneurysm closure and any strokes or complications.

What this could mean

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

Active substance
DERIVO 2heal Embolisation Device (a flow-diverting stent placed in the artery to block blood flow to the aneurysm)
What this could lead to
If successful, this device could offer a safer, more effective way to treat brain aneurysms and reduce the risk of rupture or stroke.
What could go wrong
This is a mid-stage study with 158 participants, so results may not apply to everyone. Risks include stroke, bleeding, or device-related complications like blood clots.

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 158 people

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

Started

Dec 2022

Expected to finish

Dec 2026

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

All patients who were selected for flow diversion therapy and will be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to clinical routine.

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.

Inclusion Criteria: * Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU * Age \> 18 years * Signed Informed Consent Form * Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device * Effective use of antiplatelet medication confirmed by applicable testing method according to local standard Exclusion Criteria: * Previously treated aneurysms with flow diverter, stent or WEB device * Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient * Patient with a ruptured aneurysm in the acute phase of bleeding * Pre-treatment disability (mRS \> 2) * Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel * Contraindication against treatment with anti-platelet medication * Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study * Participating in another study

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm

As listed by the trial registrant

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

Flow diverter Intracranial aneurysm

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • Klinikum Bremerhaven-Reinkenheide

    RECRUITING

    Bremerhaven, Germany

  • Klinikum Vest - Knappschaftskrankenhaus Recklinghausen

    RECRUITING

    Recklinghausen, Germany

  • Krankenhaus Nordwest Frankfurt

    RECRUITING

    Frankfurt am Main, Germany

  • Ludwig-Maximilians-Universität München

    RECRUITING

    München, Germany

  • Mühlenkreiskliniken | Johannes Wesling Klinikum Minden

    RECRUITING

    Minden, Germany

  • Städtisches Klinikum Solingen

    RECRUITING

    Solingen, Germany

  • Technische Universität München

    RECRUITING

    München, Germany

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, Germany

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, Germany

  • Universitätsklinikum Magdeburg

    RECRUITING

    Magdeburg, Germany

  • Universitätsmedizin Halle

    RECRUITING

    Halle, Germany

  • Westpfalz-Klinikum Kaiserslautern

    RECRUITING

    Kaiserslautern, Germany

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