Intracranial Aneurysms Treatment With the OPTIMA Coil System

Intracranial Aneurysm Clinical Trial

— INSTANT  

Official title:

Intracranial Aneurysms Treatment With the OPTIMA Coil System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642821
• Other study ID #: CIP-201702-OPTIMA
• Status: Completed
• 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
• 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: -

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

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