Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals

NANot yet recruitingINTERVENTIONAL
Enrollment

14,400

Participants

Timeline

Start Date

October 9, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2029

Conditions
Intracranial AneurysmCT AngiographyAI (Artificial Intelligence)Cluster Randomized Trial
Interventions
DEVICE

AI-Assisted CTA Interpretation

A locked, independently validated deep learning model was used to assist radiologists in interpreting head CTA scans. The model was trained on 16,546 CTA cases and externally validated on an independent set of 900 DSA-verified CTA cases, achieving a patient-level sensitivity of 0.943 and an average of 0.187 false positives per case.

DIAGNOSTIC_TEST

Standard CTA Interpretation

Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.

All Listed Sponsors
lead

Jinling Hospital, China

OTHER

NCT07124624 - Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals | Biotech Hunter | Biotech Hunter