Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New coils aim to seal brain aneurysms safely

NCT ID NCT03642821

Disease control Sponsor: Balt Extrusion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how safe and effective the OPTIMA coil system is for treating brain aneurysms. Researchers followed 300 patients across Europe for up to 12 months after the coiling procedure. They tracked complications like bleeding, blood clots, and the need for repeat treatment, as well as patients' overall health outcomes.

What this could mean

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

Active substance
OPTIMA coils (a device used to fill brain aneurysms from inside the blood vessel)
What this could lead to
If successful, this could confirm that the OPTIMA coil system is a safe and effective option for treating brain aneurysms, reducing the risk of rupture or rebleeding.
What could go wrong
This was an observational study without a comparison group, so it cannot prove the coils are better than other treatments. Risks include blood clots, bleeding, or the need for retreatment.

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

300 people

The number who actually took part.

Started

Mar 2019

Finished

Feb 2023

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

1. giant aneurysms (\>25 mm) 2. recanalized aneurysms initially treated with stent or flow diverter (Only aneurysms initially treated with coils are eligible) 3. aneurysm treated with parent artery occlusion 4. dissecting or fusiform aneurysms 5. aneurysms associated with an arteriovenous malformation 6. aneurysm intended to be treated with flow diverter or flow disrupter during the procedure 7. aneurysm intended to be treated in a staged procedure 8. intracranial tumor (except meningioma) 9. Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up, as requested according to sites current practice.

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: 1. Patient with small or large intracranial aneurysm, ruptured or unruptured, intended to be selectively treated with the OPTIMA coil system. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. Balloon and stent assisted coiling are allowed at index procedure. 2. In case of multiple aneurysms, patient can be included when only 1 aneurysm is treated during the procedure and none of the other aneurysms are treated up to 30 days post-procedure 3. Patient older than 18 years 4. Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations. Exclusion Criteria: \-

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coiling therapy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Coiling therapy Intracranial aneurysm

Contacts and locations

Locations

  • Antonio Cardarelli Hospital

    Naples, 80131, Italy

  • Azienda Ospedallera

    Catania, 95126, Italy

  • CHRU Strasbourg Hautepierre

    Strasbourg, 67200, France

  • CHU Charles-Nicolle

    Rouen, 76000, France

  • CHU Côte de Nâcre

    Caen, 14000, France

  • CHU Gui de Chaulliac

    Montpellier, Costalat, France

  • CHU Hôpital Maison Blanche

    Reims, 51000, France

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000, France

  • CHU de Brest - Hôpital La Cavale Blanche

    Brest, 29200, France

  • HUG Hôpital cantonal universitaire de geneva

    Geneva, CH-1211, Switzerland

  • Hospices Civils de Lyon - Hôpital Neurologique

    Bron, 69677, France

  • Hospital Universitario de Burgos

    Burgos, 09006, Spain

  • Hospital: Fundacion Jimenez Diaz

    Madrid, 28222, Spain

  • Hospital: Puerta de Hierro

    Madrid, 28222, Spain

  • Hôpital Privé Clairval

    Marseille, 13009, France

  • Medizinische Universität Innsbruck

    Innsbruck, A-6020, Austria

  • San Gerardo Hospital

    Monza, 20900, Italy

  • ULSS8 Berica Ospedale San Bortolo

    Vicenza, 36100, Italy

  • University of Latvia, Faculty of Medicine

    Riga, Latvia

  • Zentralklinikum Augsburg

    Augsburg, 86156, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.