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Completed

NCT Number: NCT07546019

Evaluation of Heuron CTA for Detecting 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.

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Key information

Conditions

Large Vessel Occlusion

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • Cases with poor-quality or incomplete brain CTA images7)
  • Cases where intracranial prosthetic implants (e.g., catheters, coils) were present
  • Cases that were previously used for AI model training and internal validation
  • 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.

Treatment and study plan

Heuron CTA

Device

This software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Heuron Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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