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

NCT07546019 | Completed

• 2 other identifiers: HR-CTA-01GCIRB2024-003
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Large Vessel Occlusion

Keywords

Heuron

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion

  Within 8 weeks after collecting data

• Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel

  Within 8 weeks after collecting data

• Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria

  Within 8 weeks after collecting data

Study Arms (2)

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

Negative group

Diagnosed as either not having large vessel occlusion or as normal after brain CTA images

Device: Heuron CTA

Interventions

Heuron CTA DEVICE

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

Negative group; Positive Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heuron Inc.: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: February 28, 2024
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)