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

This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.

NCT Number	NCT07124624
Lead Sponsor	Jinling Hospital, China
Conditions	Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence), Cluster Randomized Trial
Enrollment	14,400 participants
Start Date	2025-10-09
Primary Completion	2026-08-31 (estimated)
Study Completion	2029-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-20