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

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: Completed
• Conditions: Large Vessel Occlusion
• Intervention / Treatment: Device: Heuron CTA

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: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion	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

Outcome Measure	Measure Description	Time Frame
Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion	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	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	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

• Sponsor: Heuron Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Heuron
• Other Study ID 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