Evaluation of Heuron CTA for Detecting Suspected Large Vessel Occlusion Using Brain CT Angiography

April 15, 2026 updated by: Heuron Inc.

A Single-Center, Evaluator-Blinded, Retrospective, Pivotal Clinical Trial to Evaluate the Efficacy of Heuron CTA, a Brain Image Detection and Diagnostic Support Software, for Assessing Suspected Large Vessel Occlusion Using Brain CT Angiography

This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. If it performs well, it may help doctors diagnose these conditions more quickly and effectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to evaluate the efficacy of Heuron CTA in assisting the diagnosis of suspected large vessel occlusion using brain CT angiography. The study will determine whether Heuron CTA meets the predefined clinical success criteria, where the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%, using the final clinical diagnosis by a group of surgeons as the reference standard. If Heuron CTA meets the success criteria, it will be considered effective in assisting in the diagnosis of large vessel occlusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Namdong-gu
      • Incheon, Namdong-gu, South Korea, 21565
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

(1) Adults over 19 years old (2) Brain CTA images acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)

Description

Inclusion Criteria:

  1. Adults aged 19 years or older who visited the clinical trial institution for brain CTA images between January 2020 and May 2021, and from November 2021 until IRB approval

  2. Individuals classified into the positive or negative group based on the following criteria:

    • Positive group: Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images -- Negative group: Diagnosed as either not having large vessel occlusion or as normal after brain CTA images

Exclusion Criteria:

  1. Cases with poor-quality or incomplete brain CTA images7)
  2. Cases where intracranial prosthetic implants (e.g., catheters, coils) were present
  3. Cases that were previously used for AI model training and internal validation
  4. Any other cases deemed unsuitable for participation in the clinical trial based on the investigator's judgment * Specific reasons were recorded in the case report form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Positive Group
Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images
Device: Heuron CTA
This software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions
Negative group
Diagnosed as either not having large vessel occlusion or as normal after brain CTA images
Device: Heuron CTA
This software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion
Time Frame: Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion were assessed by calculating their 95% confidence intervals (CIs) and determining whether the lower bound exceeded the clinical success criterion of 80%. The Clopper-Pearson confidence interval method12) was used to calculate the 95% CI.
Within 8 weeks after collecting data

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion
Time Frame: Within 8 weeks after collecting data
Using the calculation method above, the accuracy for classifying suspected large vessel occlusion with a 95% confidence interval. The accuracy calculation method is the following: 100 × [TP + TN] / N. A ROC Curve was generated with the x-axis representing the false positive rate (1-specificity) and the y-axis representing sensitivity. The AUC value was calculated as the area under the ROC curve, with a 95% confidence interval provided.
Within 8 weeks after collecting data
Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel
Time Frame: Within 8 weeks after collecting data
For the positive group, Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel was calculated, along with a 95% confidence interval.
Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria
Time Frame: Within 8 weeks after collecting data
When the reference standard categories of None, Stenosis but not near occlusion, and Near occlusion were classified as "Large Vessel Occlusion Negative," and Occlusion was classified as "Large Vessel Occlusion Positive," the sensitivity and specificity of Heuron CTA were calculated along with a 95% confidence interval.
Within 8 weeks after collecting data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heuron Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-CTA-01
  • GCIRB2024-003 (Other Identifier: Gachon University Gil Medical Center IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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