Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- 90-day excellent clinical outcome
研究概览
简要总结
Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END).
Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials.
The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Randomization can be finished within 24 hours from stroke onset (stroke onset time is defined as last known well time)
- •3.NIHSS score 2-5 at the time of randomization, but must include one of the following: any consciousness disorder (≥1 on NIHSS Question #1a); partial facial paralysis (≥1 on NIHSS Question #4); any weakness limiting sustained effort against gravity (≥1 on NIHSS Question #6 or #7); severe aphasia (≥1 on NIHSS Question #9), or visual or sensory extinction (≥1 on NIHSS Question #11).
- •4.CTA or MRA proven occlusion of the Internal Carotid Artery (ICA) terminal or M1/M2 segment of Middle Cerebral Artery
- •5.CTP/MRP Imaging shows the volume of Tmax>6s ≥ 50ml.
- •Informed consent signed
排除标准
- •Pre-stroke mRS score ≥1
- •Vascular occlusion caused by special causes is not suitable for endovascular treatment, such as Moyamoya disease, arteritis, radiation vascular disease, or fibromuscular development defective, and combined intracranial tumors, aneurysms, or intracranial arteriovenous malformations;
- •Severe comorbidities or unstable conditions, such as severe heart failure, pulmonary or renal failure (serum creatinine>2.8mg/dL or 250 µ mol/L or glomerular filtration rate <30ml/min), severe liver dysfunction and malignant tumors;
- •Any active bleeding or recent bleeding (gastrointestinal bleeding, urinary bleeding, etc.) in the past six months
- •Baseline platelet count <100×109 /L;
- •Refractory abnormal blood sugar that is difficult to control by medication (50mg/dL or 2.78mmol/L or 400mg/dL or 22.2mmol/L）;
- •Angiography shows a tortuous vascular pathway, making it difficult for the experimental equipment to reach the target position or retrieve it;
- •Known severe allergy for contrast agents or anesthetics;
- •Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders)
- •10.The expected survival time is less than 1 year (such as patient with malignant tumor, advanced heart or lung diseases, etc.)
- •11.Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial;
- •Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test
研究组 & 干预措施
EVT group
In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice.
干预措施: Endovascular therapy (Procedure)
Best medical management
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
干预措施: Endovascular therapy (Procedure)
Best medical management
All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
干预措施: Best medical management (Drug)
结局指标
主要结局
90-day excellent clinical outcome
时间窗: 90±7 days after randomization
a dichotomized mRS 0-2 outcome
次要结局
- Good clinical outcome(90±7 days after randomization)
- early recovery(72 hours after randomization)