Long-term study of Optima and OptiMAX Coils in people with brain aneurysms

You may qualify if

• Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System. In addition:
• Patient age ≥ 18 years;
• Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
• OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
• Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
• Subject willing to comply with the protocol follow-up requirements; and; Hunt & Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.

You can't join if

• Since this is a real-world registry, few exclusion criteria are defined. Adjustments for baseline patient characteristics and aneurysm morphology will be used to identify outliers and unique cohorts.
• Life expectancy less than 1 year.
• Patient previously enrolled in the OPTIMA Registry.
• Known multiple intracranial aneurysms, apart from the targeted aneurysm for the OPTIMA study, requiring treatment during the index procedure or within the study follow-up period.
• Patient is unwilling or unable to comply with the protocol follow-up schedule and/or based on the Investigator's judgment the patient is not a good registry candidate.
• Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
• Pre-planned staged procedures on unruptured target aneurysms