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NCT06282939 · ClinicalTrials.gov registry record

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

A clinical trial of Intracranial Aneurysm, sponsored by HCA Healthcare Research Institute.

Recruiting
Registry status
600
Enrollment target
1
Study location

NCT06282939: Recruiting study of Intracranial Aneurysm, sponsored by HCA Healthcare Research Institute.

NCT06282939 is a study of Intracranial Aneurysm that is actively recruiting participants, run by HCA Healthcare Research Institute. The registered enrollment target is 600 participants, below the 9,153-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06282939, a study of Intracranial Aneurysm, is actively recruiting participants, sponsored by HCA Healthcare Research Institute.

RECRUITING
Registry status
600 participants
Enrollment target
1
Study location

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.

Primary Outcome

Rated by a designated core lab without retreatment as confirmed by core lab adjudication.

Conditions Studied

Interventions

  • DEVICE OPTIMA and OPTIMAX Coils manufactured by Balt USA

Study Locations (1)

Texas

  • Med City Plano - Plano

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2023-11-01
Est. Completion 2027-12-01

What NCT06282939 shows while recruiting

NCT06282939 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 9,153-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Intracranial Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which OPTIMA and OPTIMAX Coils manufactured by Balt USA is the first listed.

NCT06282939 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06282939 about?

NCT06282939 is a clinical study titled "Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry". 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 O...

What is the current status of trial NCT06282939?

This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2023-11-01. Estimated completion is 2027-12-01.

What conditions does trial NCT06282939 study?

This clinical trial studies the following conditions: Intracranial Aneurysm.

What interventions are being tested in trial NCT06282939?

The interventions under investigation include: OPTIMA and OPTIMAX Coils manufactured by Balt USA (DEVICE).

Who is sponsoring clinical trial NCT06282939?

This trial is sponsored by HCA Healthcare Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06282939 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Intracranial Aneurysm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06282939's enrollment target sits among peer trials

600 5th of 14 higher than 10 of 14 other Intracranial Aneurysm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Intracranial Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06282939, the US trial registry maintained by the National Library of Medicine. NCT06282939 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.