This observational study aims to investigate the real-world effectiveness and safety of different treatment strategies for acute ischemic stroke (AIS) in Chinese children under 18 years of age. Its primary research question is: In real-world clinical practice, does endovascular therapy (e.g., stent retriever thrombectomy, aspiration thrombectomy) improve 90-day functional outcomes in pediatric AIS patients with acute anterior or posterior circulation large vessel occlusion? Children under 18 years of age receiving routine AIS diagnosis and treatment at approximately 25-35 study centers across China will undergo neurological function assessments, imaging examinations, and evaluations of growth, development, and psychosocial status at baseline, 24 hours post-procedure, 7 days post-procedure or at hospital discharge, and at 90 days and 6 months post-onset. Adverse events will also be documented.
Study Type
OBSERVATIONAL
Enrollment
1,000
Participants receive routine clinical care per each center's standard practice. Treatment may include medical therapy (antiplatelet agents, anticoagulation) and/or endovascular treatment (stent retriever, aspiration thrombectomy, balloon angioplasty, stenting, or intra-arterial thrombolysis), as determined by the treating physician. No protocol-mandated intervention is applied.
Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days
Primary Outcome Measure assessed by the pediatric modified Rankin Scale (ped-mRS) at 90 days (±7 days) post-stroke onset. The ped-mRS is a 7-point ordinal scale (0=no symptoms to 6=death). The full ordinal distribution of scores will be analyzed as the primary efficacy endpoint.
Time frame: 90 days (±7 days) post-stroke onset
Proportion of Patients with ped-mRS 0-1, 0-2, 0-3 at 90 Days
Proportion of patients achieving favorable functional outcome, defined as pediatric modified Rankin Scale (ped-mRS) score of 0-1, 0-2, 0-3 at 90 days (±7 days) post-stroke onset.
Time frame: 90 days (±7 days) post-stroke onset
Change in ped-NIHSS Score at 24 Hours
Change in pediatric National Institutes of Health Stroke Scale (ped-NIHSS) score from baseline to 24 hours (±12 hours) post-admission/post-procedure. Higher scores indicate more severe stroke.
Time frame: 24 hours (±12 hours) post-procedure
Pediatric Modified Rankin Scale (ped-mRS) Score at 6 Months
Functional outcome assessed by ped-mRS at 6 months (±14 days) post-stroke onset. The scale ranges from 0 (no symptoms) to 6 (death).
Time frame: 6 months (±14 days) post-stroke onset
Jian Liu President, Gansu Provincial Maternity and Child-Care Hospital, MD
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