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
- 2
- 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
- •Aged 18 years or older;
- •The time from onset of acute ischemic stroke to randomization is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
- •Low NIHSS score (2-5 points), with at least one of the following items:
- •Altered mental status (lethargy or worse);
- •Facial palsy (facial weakness score ≥ 1 point);
- •Motor dysfunction (limb weakness score ≥ 1 point);
- •Aphasia (language disturbance score ≥ 1 point);
- •Hemispatial neglect (neglect score ≥ 1 point);
- •Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
- •All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
- •Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.
排除标准
- 未提供
研究组 & 干预措施
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)
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)
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)
结局指标
主要结局
90-day excellent clinical outcome
时间窗: 90±7 days after randomization
modified Rankin scale score: 0-1; , 0 \[no disablility\] to 6 \[death\]
次要结局
- Good clinical outcome(90±7 days after randomization)
- All-cause mortality rate(90±7 days after randomization)
- 90-day ordinal modified Rankin Scale score shift(90±7 days after randomization)
- Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg standard(within 48 hours after randomization)
- Rates of early neurological deterioration(at 24 hours, 72 hours, and 7 days/discharge)
- EuroQol Group 5- Dimension 5-Level (EQ-5D-5L) questionaire score(90±7 days after randomization)
- early recovery(72 hours after randomization)