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NCT Number: NCT07550257

Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China

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.

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Key information

Conditions

Acute Ischemic Stroke (AIS), Pediatric Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • Legal guardian provides signed informed consent;
  • For children aged ≥8 years to <18 years who are conscious and without comprehension impairment, assent obtained from the child;

Exclusion criteria

  • 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

Treatment and study plan

Standard clinical management

Other

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.

Primary outcomes

  1. Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days

    Time frame: 90 days (±7 days) post-stroke onset

    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.

Secondary outcomes

  1. Proportion of Patients with ped-mRS 0-1, 0-2, 0-3 at 90 Days

    Time frame: 90 days (±7 days) post-stroke onset

    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.

  2. Change in ped-NIHSS Score at 24 Hours

    Time frame: 24 hours (±12 hours) post-procedure

    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.

  3. Pediatric Modified Rankin Scale (ped-mRS) Score at 6 Months

    Time frame: 6 months (±14 days) post-stroke onset

    Functional outcome assessed by ped-mRS at 6 months (±14 days) post-stroke onset. The scale ranges from 0 (no symptoms) to 6 (death).

Other outcomes

  1. Target Vessel Final Recanalization Rate (eTICI 2b-3) on DSA

    Time frame: immediately post-procedure

    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.

  2. Target Vessel Recanalization Rate on CTA/MRA/DSA at 7 Days or Discharge

    Time frame: 7 days (±1 day) post-procedure or at 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Liu President, Gansu Provincial Maternity and Child-Care Hospital, MD

CONTACT

[email protected]

+86 13609354197

Rong Yin Chief, Division of Neurology, MD

CONTACT

[email protected]

+83 13919930466

Sponsors and collaborators

Lead sponsor

Gansu Provincial Maternal and Child Health Care Hospital

Other

Registry information

Official study title

Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China (KIDS-AIS-REGISTRY)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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