Intracranial Aneurysms Treatment With the OPTIMA Coil System

NCT03642821 | Completed

• 1 other identifier: CIP-201702-OPTIMA
• Study Type: observational
• Target: 300
• Locations: 7 countries
• Sites: 20

Brief Summary

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

Conditions

Intracranial Aneurysm; Coiling Therapy

Keywords

coil; aneurysm

Outcome Measures

Primary Outcomes (2)

• Morbi-mortality at 30 days

  Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring during the procedure and up to 30 days.

  30 days

• Clinical outcomes (mRS) at 30 days

  Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor.

  30 days

Secondary Outcomes (3)

• Morbi-mortality at 12 months

  12 months

• Clinical outcomes (mRS) at 12 months

  12 months

• Aneurysm occlusion rate

  Up to 24h and 12 months

Interventions

intracranial aneurysm coiling DEVICE

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

Also known as: OPTIMA coils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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
• Patient older than 18 years
• Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.

Sponsors & Collaborators

• Balt Extrusion: lead

Study Sites (20)

Medizinische Universität Innsbruck

Innsbruck, A-6020, Austria

Location

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

Location

CHU de Brest - Hôpital La Cavale Blanche

Brest, 29200, France

Location

Hospices Civils de Lyon - Hôpital Neurologique

Bron, 69677, France

Location

CHU Côte de Nâcre

Caen, 14000, France

Location

Hôpital Privé Clairval

Marseille, 13009, France

Location

CHU Gui de Chaulliac

Montpellier, Costalat, France

Location

CHU Hôpital Maison Blanche

Reims, 51000, France

Location

CHU Charles-Nicolle

Rouen, 76000, France

Location

CHRU Strasbourg Hautepierre

Strasbourg, 67200, France

Location

Zentralklinikum Augsburg

Augsburg, 86156, Germany

Location

Azienda Ospedallera

Catania, 95126, Italy

Location

San Gerardo Hospital

Monza, 20900, Italy

Location

Antonio Cardarelli Hospital

Napoli, 80131, Italy

Location

ULSS8 Berica Ospedale San Bortolo

Vicenza, 36100, Italy

Location

University of Latvia, Faculty of Medicine

Riga, Latvia

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital: Fundacion Jimenez Diaz

Madrid, 28222, Spain

Location

Hospital: Puerta de Hierro

Madrid, 28222, Spain

Location

HUG Hôpital cantonal universitaire de geneva

Geneva, CH-1211, Switzerland

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 22, 2018
• Study Start: March 1, 2019
• Primary Completion: October 13, 2021
• Study Completion: February 15, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); AU (1); CH (1); LA (1); DE (1); FR (9); IT (4)