The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction

Официальное название

The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial

Обзор

This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial

Подробное описание

This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)

Вмешательства

• Процедура Endovascular Recanalization Strategy
  The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed duri
• Препарат Best Medical Management
  Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in t

Первичные конечные точки

• Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization [Срок оценки: 90±14 days after randomization]

Вторичные конечные точки (9)

• MRS score as an ordinal scale at 90 (±14) days after randomization [Срок оценки: 90±14 days after randomization]
• Rate of mRS 0-2 at 90 (±14) days after randomization [Срок оценки: 90±14 days after randomization]
• National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization [Срок оценки: 24 hours after randomization]
• NIHSS score at 7 days after randomization or discharge (whichever came first) [Срок оценки: 7 days after randomization or at discharge]
• Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization [Срок оценки: 90±14 days after randomization]
• The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization [Срок оценки: 90±14 days after randomization]
• Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD) [Срок оценки: 18-36 hours after randomization]
• Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3) [Срок оценки: At the end of the operation]
• The proportion of mRS 0-4 at 90 (± 14) days after randomization [Срок оценки: 90±14 days after randomization]

Критерии участия

Критерии включения

• The age ranged from 18 to 80 years
• Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
• Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
• Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
• NIHSS score ≥10 before randomization
• Pre-stroke mRS of 0-2
• Each patient or their legal representative must provide written informed consent before enrolment

Критерии исключения

• Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
• Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
• Known or highly suspected chronic occlusion of basilar artery
• History of contraindication for contrast medium (except mild rash)
• Current pregnant or breast-feeding
• Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
• Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
• It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
• Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
• Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
• Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
• CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
• Central nervous system vasculitis has been diagnosed or clinically suspected
• Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
• Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
• Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07333950 · HX-A-2025081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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