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

April 19, 2026 updated by: Gansu Provincial Maternal and Child Health Care Hospital

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jian Liu President, Gansu Provincial Maternity and Child-Care Hospital, MD
  • Phone Number: +86 13609354197
  • Email: Medecinliu@sina.com

Study Contact Backup

  • Name: Rong Yin Chief, Division of Neurology, MD
  • Phone Number: +83 13919930466
  • Email: yin_rong_@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All eligible children aged 28 days to <18 years with acute ischemic stroke (AIS) enrolled consecutiv
All eligible children aged 28 days to <18 years with acute ischemic stroke (AIS) enrolled consecutively from approximately 25-35 participating centers in China. Patients receive standard clinical management without treatment restrictions. Data collected include baseline demographics, clinical presentation, treatment strategies (medical therapy alone or endovascular treatment including stent retrieval, aspiration, balloon angioplasty, stenting, or intra-arterial thrombolysis), imaging parameters, safety outcomes, and functional outcomes assessed by pediatric modified Rankin Scale (ped-mRS) at 90 days and 6 months.
Other: Standard Clinical Management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days (±7 days) post-stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days (±7 days) post-stroke onset
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.
24 hours (±12 hours) post-procedure
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).
6 months (±14 days) post-stroke onset

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately post-procedure
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.
7 days (±1 day) post-procedure or at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gansu Provincial Maternal and Child Health Care Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026GSFYLS017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and regulatory restrictions: enrollment of pediatric participants (age <18 years), collection of sensitive clinical, imaging, and biospecimen data (blood and thrombus samples), and compliance with Chinese human genetic resources management regulations. Informed consent obtained does not include provisions for public sharing of individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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