Intracranial Aneurysms Treatment With the OPTIMA Coil System

Balt Extrusion300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Intracranial Aneurysm Coiling Therapy

Interventions

intracranial aneurysm coilingDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (20)

Medizinische Universität Innsbruck

Innsbruck, Austria

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 days

Secondary Outcomes

Morbi-mortality at 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.

Time frame: 12 months

Clinical outcomes (mRS) at 12 months

Time frame: 12 months

Aneurysm occlusion rate

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).

Time frame: Up to 24h and 12 months

Data from ClinicalTrials.gov

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