Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Recruiting · NCT06282939
Conditions: Intracranial Aneurysm
At a glance
- Research payments reported, 2025
- $221,238
- U.S. investigators named
- 2
- Sites paid
- 1
- Planned or actual enrollment
- 600
About the trial
- Sponsor
- HCA Healthcare Research Institute (with Balt USA)
- Tested
- OPTIMA and OPTIMAX Coils manufactured by Balt USA (device)
- Dates
- Started 2023-11-01; completion 2027-12-01
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2024-02-28. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Balt USA, LLC reported $221,238 in research payments for this study in 2025 (80 payments).
Products named: Optima Coil System
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- HCA Research Institute, LLC $221,238
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.