Evaluating the Optima Coil System for treating intracranial aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to assess the safety and effectiveness of the Optima Coil System, including OptiMAX Coils, in treating patients with intracranial aneurysms. The study will enroll approximately 600 patients across multiple clinical sites in the U.S., focusing on both ruptured and unruptured saccular aneurysms. Imaging data will be analyzed by a core neuroimaging lab to evaluate procedural success and aneurysm occlusion rates. The study will not involve formal hypothesis testing but will provide descriptive statistics and identify predictors of treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.

In addition:

1. Patient age ≥ 18 years;
2. Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
3. OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
4. Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
5. Subject willing to comply with the protocol follow-up requirements; and
6. Hunt \& Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.

Exclusion Criteria:

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.

1. Life expectancy less than 1 year.
2. Patient previously enrolled in the OPTIMA Registry.
3. 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.
4. 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.
5. Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
6. Pre-planned staged procedures on unruptured target aneurysms

Where it's running

• Med City Plano
  Plano, Texas, United States Recruiting

Study contacts

• Principal investigator: Albert Yoo — HCA Research Institute
• Study coordinator: Allison Kiser
• Email: allison.kiser@hcahealthcare.com
• Phone: 812-617-5328

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flow Diverter Stent for Intracranial Aneurysm in China

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• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.