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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days (±7 days) post-stroke onset |
| Change in ped-NIHSS Score at 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26758911 | Result | 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. | |
| 21960577 |
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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.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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 | 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 |
| 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. |
| 7 days (±1 day) post-procedure or at discharge |
| 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. |
| 10905241 | 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. |
| 23390038 | 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. |
| 40533220 | 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. |
| 39351662 | 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. |
| 39401507 | 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. |
| 34331864 | 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. |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |