Evaluating the Optima Coil System for treating intracranial aneurysms

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

This study is testing the safety and effectiveness of the Optima Coil System for treating people with intracranial aneurysms, whether they are ruptured or not.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HCA Healthcare Research Institute (other)
• Locations: 1 site (Plano, Texas)
• Trial ID: NCT06282939 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with previously untreated saccular intracranial aneurysms suitable for embolization.

Not a fit: Patients with aneurysms that do not meet the size or treatment criteria, or those with severe Hunt & Hess classification (greater than 4 for ruptured aneurysms), may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance treatment strategies for patients with intracranial aneurysms, potentially improving safety and efficacy outcomes.

How similar studies have performed: While this approach is based on existing coil technology, the specific evaluation of the Optima Coil System in a real-world setting is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Plano, Texas

• Med City Plano — Plano, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Albert Yoo — HCA Research Institute
• Study coordinator: Allison Kiser

Conditions: Intracranial Aneurysm