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.

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.

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.