Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving mRS 0-3 at 90 Days
研究概览
简要总结
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Clinical exclusion criteria:
- •Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.
- •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).
研究组 & 干预措施
Endovascular Therapy Plus Best Medical Treatment
Patients randomized to this arm will receive endovascular therapy (EVT) in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours.The EVT strategy will be selected by the treating neurointerventionalist based on vascular findings. Allowed procedures include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or a combination of these.
干预措施: Endovascular Therapy Plus Best Medical Treatment (Procedure)
Best Medical Treatment Alone
Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed.
干预措施: Best Medical Treatment Alone (Drug)
结局指标
主要结局
Proportion of Patients Achieving mRS 0-3 at 90 Days
时间窗: 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome.
次要结局
- Proportion of basilar artery recanalization(24 hours (-2/+12 hours))
- Ordinal Shift analysis of mRS at 90 days(90 days)
- Dichotomized mRS score (0-2 versus 3-6 )(90 days)
- Proportion of Patients Achieving mRS 0-4 at 90 Days(90 days)
- Barthel Index(90 days)
- Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months(6 months)
- Dramatic early favorable response(24 (-2/+12) hours)
- Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months(12 months)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University