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Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Sponsor: HCA Healthcare Research Institute
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
Conditions
Interventions
OPTIMA and OPTIMAX Coils manufactured by Balt USA
\*Percentage from protocol
Locations (1)
Med City Plano
Plano, Texas, United States