NCT06282939

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: HCA Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The core lab will consist of 4-5 physicians, 2-3 from within HCA Healthcare, and 2-3 from outside of HCA Healthcare. Core lab physicians will be blinded to patient characteristics for HIPAA compliance. Physicians within the core lab will not be principal investigators enrolling patients in the study. 600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System. As this is a registry, there will be no formal hypothesis testing of the study endpoints, and no formal sample size / power calculations will be performed. Approximately 600 subjects will be enrolled in the registry at up to 12 clinical sites in the US. Data analyses will be performed and led by the study PIs, Site PIs, and Sub-investigators. Expected descriptive statistics will include baseline patient demographics, procedural characteristics, radiographic parameters, safety outcomes, clinical and efficacy outcomes. Pilot univariate and multivariate logistic regression will be performed on the intention-to-treat cohort to identify predictors of adequate and complete aneurysm occlusion.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	OPTIMA and OPTIMAX Coils manufactured by Balt USA	\*Percentage from protocol

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study