Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Part of paid clinical trials in Plano, Texas.

Sponsor
HCA Healthcare Research Institute
Study ID
NCT06282939
Status
Recruiting
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Conditions

  • Intracranial Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OPTIMA and OPTIMAX Coils manufactured by Balt USA — DEVICE
    \*Percentage from protocol

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Feb 2024
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score [ Time Frame: 1 year follow up +/- 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Med City PlanoPlanoTexas75075
Albert Yoo
[email protected]
972-566-5411
Pauline Matheri
[email protected]
615-329-7274

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By research site
Med City Plano· Plano, TX

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