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RECRUITING
NCT06282939

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Sponsor: HCA Healthcare Research Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2023-11-01

Completion Date

2027-12-01

Last Updated

2024-02-28

Healthy Volunteers

No

Interventions

DEVICE

OPTIMA and OPTIMAX Coils manufactured by Balt USA

\*Percentage from protocol

Locations (1)

Med City Plano

Plano, Texas, United States