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.
Age >28 days and <18 years;
Presence of stroke-related symptoms (hemiparesis, facial palsy, aphasia, altered level of consciousness, seizure, headache) or atypical symptoms (sudden lethargy or irritability, crying, feeding difficulties, incontinence, sensory loss, ataxia, vertigo, nausea and/or vomiting, neck pain, fever);
First-ever stroke and onset within ≤7 days prior to admission;
Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
Lack of imaging examination or stroke diagnosed without imaging
History of hypoxic-ischemic encephalopathy
Ischemic stroke caused by cerebral venous system
Concurrent presence of indistinguishable ischemic and hemorrhagic stroke
This study will prospectively enroll consecutive patients aged 28 days to \<18 years with acute ischemic stroke (AIS) from approximately 25-35 participating centers across China. Eligible patients must have first-ever stroke with onset ≤7 days prior to admission, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). Both patients receiving standard medical therapy alone and those receiving endovascular treatment (including stent retrieval, aspiration thrombectomy, balloon angioplasty, stenting, or intra-arterial thrombolysis) will be included. Patients with lack of imaging confirmation, history of hypoxic-ischemic encephalopathy, ischemic stroke caused by cerebral venous system, or concurrent indistinguishable ischemic and hemorrhagic stroke will be excluded. The study aims to enroll a target sample size of \>1000 patients.
Cohort
Prospective
Standard Clinical Management
Other interventionParticipants 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.
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.
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.
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).
Target Vessel Final Recanalization Rate (eTICI 2b-3) on DSA
Proportion of endovascular-treated patients achieving extended Thrombolysis in Cerebral Infarction (eTICI) grade 2b-3 on final digital subtraction angiography (DSA) assessment. eTICI 2b indicates ≥50% reperfusion, eTICI 3 indicates 100% reperfusion.
Target Vessel Recanalization Rate on CTA/MRA/DSA at 7 Days or Discharge
Proportion of endovascular-treated patients achieving target vessel recanalization assessed by CTA, MRA, or DSA at 7 days (±1 day) post-procedure or at discharge.
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