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New coils aim to seal brain aneurysms safely

NCT ID NCT03642821

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

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.

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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.

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

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