Clinical trial NCT03642821: Intracranial Aneurysms Treatment With the OPTIMA Coil System
Official title: Intracranial Aneurysms Treatment With the OPTIMA Coil System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Balt Extrusion
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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:

-

Primary outcomes:
measure: Morbi-mortality at 30 days
timeFrame: 30 days
measure: Clinical outcomes (mRS) at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Morbi-mortality at 12 months
timeFrame: 12 months
measure: Clinical outcomes (mRS) at 12 months
timeFrame: 12 months
measure: Aneurysm occlusion rate
timeFrame: Up to 24h and 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Brest
country: France
facility: CHU de Brest - Hôpital La Cavale Blanche
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Neurologique
city: Caen
country: France
facility: CHU Côte de Nâcre
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Montpellier
country: France
facility: CHU Gui de Chaulliac
city: Reims
country: France
facility: CHU Hôpital Maison Blanche
city: Rouen
country: France
facility: CHU Charles-Nicolle
city: Strasbourg
country: France
facility: CHRU Strasbourg Hautepierre
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Catania
country: Italy
facility: Azienda Ospedallera
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Napoli
country: Italy
facility: Antonio Cardarelli Hospital
city: Vicenza
country: Italy
facility: ULSS8 Berica Ospedale San Bortolo
city: Riga
country: Latvia
facility: University of Latvia, Faculty of Medicine
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital: Puerta de Hierro
city: Geneva
country: Switzerland
facility: HUG Hôpital cantonal universitaire de geneva
Study officials:
References: