Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct

Официальное название

Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial

Обзор

This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.

Подробное описание

This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.

Вмешательства

• Процедура Endovascular Therapy Plus Best Medical Treatment
  Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thromb
• Препарат Best Medical Treatment Alone
  Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.

Первичные конечные точки

• Proportion of Patients Achieving mRS 0-3 at 90 Days [Срок оценки: 90 days]

Вторичные конечные точки (8)

• Dramatic early favorable response [Срок оценки: 24 (-2/+12) hours]
• Ordinal Shift analysis of mRS at 90 days [Срок оценки: 90 days]
• Dichotomized mRS score (0-2 versus 3-6 ) [Срок оценки: 90 days]
• Proportion of Patients Achieving mRS 0-4 at 90 Days [Срок оценки: 90 days]
• Barthel Index [Срок оценки: 90 days]
• Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months [Срок оценки: 6 months]
• Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months [Срок оценки: 12 months]
• Proportion of basilar artery recanalization [Срок оценки: 24 hours (-2/+12 hours)]

Критерии участия

Критерии включения

• Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
• Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
• Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
• Age ≥18 and ≤80 years.
• Baseline NIHSS score ≥6 at the time of randomization.
• No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
• Informed consent obtained from patient or acceptable patient surrogate.

Критерии исключения

Clinical exclusion criteria:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
• Baseline platelet count < 50000/µL.
• Baseline blood glucose of < 50mg/dL or >400mg/dL.
• Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
• Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life threatening allergy (more than rash) to contrast medium.
• Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
• Renal insufficiency with creatinine ≥ 3 mg/dL.
• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Known diagnosis or clinical suspicion of cerebral vasculitis.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).

Neuroimaging exclusion criteria:

• Pons-midbrain-index of ≥ 4 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
• CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
• Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
• Complete bilateral thalamic infarction on CT or MRI.
• Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
• Subjects with occlusions in both anterior and posterior circulation.
• Evidence of intracranial tumor (except small meningioma).

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

• Xuanwu Hospital — Пекин

Идентификаторы

NCT: NCT07046299 · BAOCHE3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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