NCT06282939 Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
| NCT ID | NCT06282939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HCA Healthcare Research Institute |
| Condition | Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2023-11-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.
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
Contact & Investigator
Albert Yoo
PRINCIPAL INVESTIGATOR
HCA Research Institute
Frequently Asked Questions
Who can join the NCT06282939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06282939 currently recruiting?
Yes, NCT06282939 is actively recruiting participants. Contact the research team at allison.kiser@hcahealthcare.com for enrollment information.
Where is the NCT06282939 trial being conducted?
This trial is being conducted at Plano, United States.
Who is sponsoring the NCT06282939 clinical trial?
NCT06282939 is sponsored by HCA Healthcare Research Institute. The principal investigator is Albert Yoo at HCA Research Institute. The trial plans to enroll 600 participants.