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.
None
Age < 18 years
History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)
Modified Rankin Scale (mRS) score > 3
Refuse to sign written informed consent
Sequential
AI-Assisted CTA Interpretation
DeviceA 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.
Standard CTA Interpretation
Diagnostic testHead CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.
Detection rate of intracranial aneurysms
The proportion of patients diagnosed with intracranial aneurysms among all individuals undergoing CTA during the observation period. This outcome is used to compare the diagnostic effectiveness of conventional radiologist interpretation based on local clinical practice versus AI-assisted diagnosis in detecting intracranial aneurysms.
Detection rates of other intracranial lesions except aneurysms
The proportion of patients diagnosed with intracranial arterial stenosis, occlusion, arteriovenous malformation (AVM), Moyamoya disease, or other vascular abnormalities among all individuals undergoing CTA during the observation period.
Follow-up visits and referrals
The number of follow-up or referral visits, including the number of follow-up visits, number of referrals, and repeated noninvasive vascular imaging examinations (e.g., CTA, MRA, or high-resolution vessel wall MRI).
Hospitalization
Subsequent hospitalization outcomes during patient follow-up, including the rate of hospitalization, rate of hospitalization specifically related to intracranial aneurysms and the length of hospital stay.
Invasive DSA examinations
Rate of patients undergoing digital subtraction angiography (DSA), along with the distribution of findings, including positive identification of aneurysms, other vascular abnormalities, or no detectable abnormalities.
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