MedTrace Logo

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

NCT06282939 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

OPTIMA and OPTIMAX Coils manufactured by Balt USA

\*Percentage from protocol

Sponsors & Collaborators

  • Balt USA

    collaborator INDUSTRY

  • HCA Healthcare Research Institute

    lead OTHER

Principal Investigators

  • Albert Yoo · HCA Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06282939 on ClinicalTrials.gov