Intracranial Aneurysms Treatment With the OPTIMA Coil System

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03642821
• Lead Sponsor: Balt Extrusion

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Study Start: 2019-03-01
• Primary Completion: 2021-10-13
• Status Verified: 2023-02
• Study Completion: 2023-02-15
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbi-mortality at 30 days	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.
Clinical outcomes (mRS) at 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Morbi-mortality at 12 months	12 months	Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring within 12 months after the procedure.
Clinical outcomes (mRS) at 12 months	12 months	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.
Aneurysm occlusion rate	Up to 24h and 12 months	Post-procedure and 12-month follow-up efficacy based on the assessment of the aneurysm occlusion rate according to the 3-grade Montreal scale (complete occlusion/neck remnant/aneurysm remnant).

Trial Locations

Locations (20)

University of Latvia, Faculty of Medicine; 🇱🇻 Riga, Latvia

Hôpital Privé Clairval; 🇫🇷 Marseille, France

Azienda Ospedallera; 🇮🇹 Catania, Italy

San Gerardo Hospital; 🇮🇹 Monza, Italy

CHU de Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

CHU Hôpital Maison Blanche; 🇫🇷 Reims, France

CHU Charles-Nicolle; 🇫🇷 Rouen, France

Zentralklinikum Augsburg; 🇩🇪 Augsburg, Germany

CHU de Brest - Hôpital La Cavale Blanche; 🇫🇷 Brest, France

CHRU Strasbourg Hautepierre; 🇫🇷 Strasbourg, France

HUG Hôpital cantonal universitaire de geneva; 🇨🇭 Geneva, Switzerland

Hospital: Puerta de Hierro; 🇪🇸 Madrid, Spain

CHU Côte de Nâcre; 🇫🇷 Caen, France

CHU Gui de Chaulliac; 🇫🇷 Montpellier, France

Hospices Civils de Lyon - Hôpital Neurologique; 🇫🇷 Bron, France

Antonio Cardarelli Hospital; 🇮🇹 Napoli, Italy

ULSS8 Berica Ospedale San Bortolo; 🇮🇹 Vicenza, Italy

Hospital: Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria