Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Recruiting
Observational Study
Intracranial Aneurysm
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 600 (estimated)
- Sponsor
- HCA Healthcare Research Institute · Other
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About This Trial
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 d…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.
In addition:
1. Patient age ≥ 18 years;
2. Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal dia…
Contacts