Intracranial Aneurysms Treatment With the OPTIMA Coil System

NCT ID: NCT03642821

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-02-15

Brief Summary

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International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy

Detailed Description

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Conditions

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Intracranial Aneurysm Coiling Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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intracranial aneurysm coiling

endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system

Intervention Type DEVICE

Other Intervention Names

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OPTIMA coils

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balt Extrusion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status

CHU de Brest - Hôpital La Cavale Blanche

Brest, , France

Site Status

Hospices Civils de Lyon - Hôpital Neurologique

Bron, , France

Site Status

CHU Côte de Nâcre

Caen, , France

Site Status

Hôpital Privé Clairval

Marseille, , France

Site Status

CHU Gui de Chaulliac

Montpellier, , France

Site Status

CHU Hôpital Maison Blanche

Reims, , France

Site Status

CHU Charles-Nicolle

Rouen, , France

Site Status

CHRU Strasbourg Hautepierre

Strasbourg, , France

Site Status

Zentralklinikum Augsburg

Augsburg, , Germany

Site Status

Azienda Ospedallera

Catania, , Italy

Site Status

San Gerardo Hospital

Monza, , Italy

Site Status

Antonio Cardarelli Hospital

Napoli, , Italy

Site Status

ULSS8 Berica Ospedale San Bortolo

Vicenza, , Italy

Site Status

University of Latvia, Faculty of Medicine

Riga, , Latvia

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital: Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital: Puerta de Hierro

Madrid, , Spain

Site Status

HUG Hôpital cantonal universitaire de geneva

Geneva, , Switzerland

Site Status

Countries

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Austria France Germany Italy Latvia Spain Switzerland

Other Identifiers

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CIP-201702-OPTIMA

Identifier Type: -

Identifier Source: org_study_id

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