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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03642821
Other study ID # CIP-201702-OPTIMA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date February 15, 2023

Study information

Verified date February 2023
Source Balt Extrusion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date February 15, 2023
Est. primary completion date October 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Medizinische Universität Innsbruck Innsbruck
France CHU de Bordeaux - Hôpital Pellegrin Bordeaux
France CHU de Brest - Hôpital La Cavale Blanche Brest
France Hospices Civils de Lyon - Hôpital Neurologique Bron
France CHU Côte de Nâcre Caen
France Hôpital Privé Clairval Marseille
France CHU Gui de Chaulliac Montpellier
France CHU Hôpital Maison Blanche Reims
France CHU Charles-Nicolle Rouen
France CHRU Strasbourg Hautepierre Strasbourg
Germany Zentralklinikum Augsburg Augsburg
Italy Azienda Ospedallera Catania
Italy San Gerardo Hospital Monza
Italy Antonio Cardarelli Hospital Napoli
Italy ULSS8 Berica Ospedale San Bortolo Vicenza
Latvia University of Latvia, Faculty of Medicine Riga
Spain Hospital Universitario de Burgos Burgos
Spain Hospital: Fundacion Jimenez Diaz Madrid
Spain Hospital: Puerta de Hierro Madrid
Switzerland HUG Hôpital cantonal universitaire de geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
Balt Extrusion

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Latvia,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 12 months
Secondary Clinical outcomes (mRS) at 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. 12 months
Secondary 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). Up to 24h and 12 months
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