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

NCT07550257 | Not Yet Recruiting DMC

• 1 other identifier: 2026GSFYLS017
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke (AIS), Pediatric Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days (±7 days) post-stroke onset

Secondary Outcomes (3)

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

  90 days (±7 days) post-stroke onset

• Change in ped-NIHSS Score at 24 Hours

  24 hours (±12 hours) post-procedure

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

  6 months (±14 days) post-stroke onset

Other Outcomes (2)

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

  immediately post-procedure

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

  7 days (±1 day) post-procedure or at discharge

Study Arms (1)

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

Interventions

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.

All eligible children aged 28 days to <18 years with acute ischemic stroke (AIS) enrolled consecutiv

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Gansu Provincial Maternal and Child Health Care Hospital: lead

Related Publications (9)

• Chandra RV, Leslie-Mazwi TM, Mehta BP, Derdeyn CP, Demchuk AM, Menon BK, Goyal M, Gonzalez RG, Hirsch JA. Does the use of IV tPA in the current era of rapid and predictable recanalization by mechanical embolectomy represent good value? J Neurointerv Surg. 2016 May;8(5):443-6. doi: 10.1136/neurintsurg-2015-012231. Epub 2016 Jan 12.

  PMID: 26758911 RESULT

• Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29.

  PMID: 21960577 RESULT

• Barber PA, Demchuk AM, Zhang J, Buchan AM. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet. 2000 May 13;355(9216):1670-4. doi: 10.1016/s0140-6736(00)02237-6.

  PMID: 10905241 RESULT

• Goyal M, Fargen KM, Turk AS, Mocco J, Liebeskind DS, Frei D, Demchuk AM. 2C or not 2C: defining an improved revascularization grading scale and the need for standardization of angiography outcomes in stroke trials. J Neurointerv Surg. 2014 Mar;6(2):83-6. doi: 10.1136/neurintsurg-2013-010665. Epub 2013 Feb 6. No abstract available.

  PMID: 23390038 RESULT

• Zhang W, Zhu B, Cai G, Niu M, Duan C, Zhang P, Xu Y, Xiao L, Li Q, Su Z, Wu F, Li W, Wang H, Sun W. Current status and prognostic factors of paediatric arterial ischaemic stroke in China: a study protocol for Chinese Paediatric Ischaemic Stroke Registry (CPISR). BMJ Open. 2025 Jun 18;15(6):e093718. doi: 10.1136/bmjopen-2024-093718.

  PMID: 40533220 RESULT

• Tudorache R, Kossorotoff M, Kerleroux B, Denier C, Naggara O, Boulouis G; KID-CLOT Group. Determinants of Timely Access to Recanalization Treatments and Outcomes in Pediatric Ischemic Stroke. Stroke. 2024 Nov;55(11):2716-2719. doi: 10.1161/STROKEAHA.124.046417. Epub 2024 Oct 1.

  PMID: 39351662 RESULT

• Sporns PB, Bhatia K, Abruzzo T, Pabst L, Fraser S, Chung MG, Lo W, Othman A, Steinmetz S, Jensen-Kondering U, Schob S, Kaiser DPO, Marik W, Wendl C, Kleffner I, Henkes H, Kraehling H, Nguyen-Kim TDL, Chapot R, Yilmaz U, Wang F, Hafeez MU, Requejo F, Limbucci N, Kauffmann B, Mohlenbruch M, Nikoubashman O, Schellinger PD, Musolino P, Alawieh A, Wilson J, Grieb D, Gersing AS, Liebig T, Olivieri M, Schwabova JP, Tomek A, Papanagiotou P, Boulouis G, Naggara O, Fox CK, Orlov K, Kuznetsova A, Parra-Farinas C, Muthusami P, Regenhardt RW, Dmytriw AA, Burkard T, Martinez M, Brechbuhl D, Steinlin M, Sun LR, Hassan AE, Kemmling A, Lee S, Fullerton HJ, Fiehler J, Psychogios MN, Wildgruber M. Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study. Lancet Child Adolesc Health. 2024 Dec;8(12):882-890. doi: 10.1016/S2352-4642(24)00233-5. Epub 2024 Oct 11.

  PMID: 39401507 RESULT

• Sporns PB, Fullerton HJ, Lee S, Kirton A, Wildgruber M. Current treatment for childhood arterial ischaemic stroke. Lancet Child Adolesc Health. 2021 Nov;5(11):825-836. doi: 10.1016/S2352-4642(21)00167-X. Epub 2021 Jul 29.

  PMID: 34331864 RESULT

• 中华医学会儿科学分会神经学组. 儿童动脉缺血性脑卒中诊疗专家共识[J]. 中华儿科杂志, 2022, 60(12): 1248-1252.

  RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

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

CONTACT

+86 13609354197; Medecinliu@sina.com

Rong Yin Chief, Division of Neurology, MD

CONTACT

+83 13919930466; yin_rong_@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share