Intracranial Aneurysms Treatment With the OPTIMA Coil System (INSTANT)

Balt

Status: Completed

Conditions: Coiling Therapy; Intracranial Aneurysm

Treatments: Device: intracranial aneurysm coiling

Study type: Observational

Funder types: Industry

Identifiers

NCT03642821

CIP-201702-OPTIMA

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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