Condition: Intracranial Aneurysm · Sponsor: HCA Healthcare Research Institute
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.
This description comes directly from the study's public registry record.
Allison Kiser · 812-617-5328 · allison.kiser@hcahealthcare.com
Gina Remington · 352-745-0055 · gina.remington@hcahealthcare.com
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| Med City Plano | Plano, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06282939