Who is eligible for clinical trial NCT06282939?

Participants must meet protocol criteria for Intracranial Aneurysm. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06282939 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-02-21

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry (NCT06282939)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: HCA Healthcare Research Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: Med City Plano — Plano, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Med City Plano — Plano, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗