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NCT06282939: OPTIMA

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Recruiting now Last updated 28 February 2024
What this trial tests

trial testing OPTIMA and OPTIMAX Coils manufactured by Balt USA in Intracranial Aneurysm in 600 participants. Currently enrolling.

Timeline
1 November 2023
Primary endpoint
1 December 2026
1 December 2027

Quick facts

Lead sponsorHCA Healthcare Research Institute
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date1 November 2023
Primary completion1 December 2026
Estimated completion1 December 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Intracranial Aneurysm

Currently open trials in the same condition.

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Data sources for this page

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