NCT06560203招募中不适用
Safety and Efficacy of Endovascular Treatment for Acute Basilar Artery Occlusion in the Extended Time Window -a Prospective, Multicenter, Randomized Controlled, Open-label Clinical Trial
Capital Medical University1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2024年9月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
研究概览
简要总结
A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window
详细描述
This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well. In this trial, the randomization will employ a 2:1 ratio of mechanical thrombectomy versus best medical management alone. Randomization will be stratified according to age (18-70 or >70), baseline NIHSS (6-20 or >20) and therapeutic window (24-48 hours or >48 hours). For the primary endpoint, subjects will be followed for 90 days post-randomization.
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 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.
- •Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
- •Age ≥18 and ≤
- •Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
- •No significant pre-stroke functional disability (mRS ≤ 1).
- •Patient treatable within 72 hours of symptom onset. Symptom onset is defined as the point in time the patient was last seen well (at baseline) if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history.
- •Informed consent obtained from patient or authorized patient surrogate
排除标准
- •Clinical 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. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.).
- •Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- •Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
- •Neuroimaging criteria
- •Hypodensity with a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) < 6 and Pons-midbrain-index of ≥ 3 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).
结局指标
主要结局
Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
时间窗: 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
次要结局
- Dramatic early favorable response(24 (-2/+12) hours)
- Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)(90 days)
- Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months.(12 months)
- Barthel Index at 90 days(90 days)
- Dichotomized mRS score (0-2 versus 3-6 )(90 days)
- Ordinal Shift analysis of mRS at 90 days(90 days)
- Proportion of basilar artery recanalization(24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm))
- Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months.(12 months)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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