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NCT06282939: OPTIMA
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
trial testing OPTIMA and OPTIMAX Coils manufactured by Balt USA in Intracranial Aneurysm in 600 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | HCA Healthcare Research Institute |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 1 November 2023 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- OPTIMA and OPTIMAX Coils manufactured by Balt USA
Conditions studied
- Intracranial Aneurysm — all drugs for Intracranial Aneurysm →
Sponsor
HCA Healthcare Research Institute
Who can join
18 and older, any sex, with Intracranial Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06282939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06282939 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HCA Healthcare Research Institute
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06282939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing