[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602523":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":42,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Jinling Hospital, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Assisted Diagnosis","EXPERIMENTAL","Patients in this group will undergo head CTA, interpreted by radiologists with the assistance of a previously validated deep learning AI model. The model highlights suspected aneurysm candidates on the CTA images to support diagnostic decision-making.",[13],"Device: AI-Assisted CTA Interpretation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Diagnosis","ACTIVE_COMPARATOR","Patients in this group will undergo head CTA, which will be interpreted by radiologists following standard local diagnostic protocols. No AI assistance will be provided during image interpretation.",[19],"Diagnostic Test: Standard CTA Interpretation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DIAGNOSTIC_TEST","Standard CTA Interpretation","Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Longjiang Zhang, Ph.D, MD","CONTACT","+8613405833176","kevinzhlj@163.com",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Bin Hu, MS","+8618851088705","hubin011601@163.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zhang longjiang,MD","Head of Radiology","100602523","stepped-wedge-cluster-randomized-trial-of-ai-assisted-cta-detection-for-intracranial-aneurysms-in-regional-hospitals-100602523",false,"NCT07124624","Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals","Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial","IDEAL2","Inclusion Criteria:\n\n-Patients in the outpatient setting who are scheduled to undergo head CTA scanning\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)\n* Modified Rankin Scale (mRS) score \\> 3\n* Refuse to sign written informed consent\n* Contraindications to CTA examination\n* CTA scan failure, incomplete imaging data, or image quality insufficient for diagnostic evaluation",true,"ALL","18 Years",{"count":58,"type":59},14400,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.",[65,66,67,68],"Intracranial Aneurysm","CT Angiography","AI (Artificial Intelligence)","Cluster Randomized Trial",[70,67,71],"Intracranial aneurysm","Stepped-wedge cluster-randomized trial","NOT_YET_RECRUITING","2025-08-15",{"date":75,"type":76},"2025-08-20","ACTUAL",{"date":78,"type":59},"2025-10-09",{"date":80,"type":59},"2029-08-31",{"name":5,"class":6}]