Automated detection of large vessel occlusion using deep learning: a pivotal multicenter clinical trial and reader assessment study

Abstract Background This multicenter clinical trial evaluated the stand-alone efficacy and the improvements in diagnostic accuracy of early-career physicians using a deep learning-based software to detect large vessel occlusion (LVO) in CT angiography (CTA). Methods This multicenter pivotal clinical trial included 595 ischemic stroke patients from January 2018 to September 2023. Standard reference and LVO locations (intracranial internal carotid artery ICA, M1, or M2) were determined by consensus among three expert vascular neurologists after reviewing CTA, MR imaging, and symptom data. The performance of the JLK-LVO software was evaluated against a standard reference, and its impact on the diagnostic accuracy of four residents involved in stroke care was assessed. Performance metrics included the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results Among the 595 patients (mean age 68.5 ± 13.4 years, 56% male), 275 (46.2%) had LVO. The median time interval from the last known well moment to the CTA was 46 hours (IQR 11.8 to 64.4). For LVO detection, the software demonstrated a sensitivity of 86% and a specificity of 97%. For isolated M2 occlusions, it achieved a sensitivity of 69% and a specificity of 96%. The reader assessment study showed that reading with software assistance improved the sensitivity by 4.0% and AUROC by 2.4% (all p < 0.001) compared to readings without AI assistance. Conclusion The software demonstrated a high detection rate for proximal LVO and moderate sensitivity for isolated MCA-M2 occlusion. In addition, the software improved diagnostic accuracy of early-career physicians in detecting LVO.