NCT06464731招募中不适用
Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry
Wen-huo Chen9 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月1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
- 200
- 试验地点
- 9
- 主要终点
- The rate of excellent outcome
研究概览
简要总结
Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.
详细描述
The purpose of this registry is to select patients with mild AIS caused by anterior circulation LVO with mismatched volume of the ischemic penumbra based on screen of cerebral perfusion imaging. This registry aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age 18-80 years old;
- •Symptoms onset or last known well to randomization is within 24 hours.
- •Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery [ICA], middle cerebral artery [MCA] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;
- •Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
- •ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization;
排除标准
- •Premorbid Rankin Scale (mRS) score ≥ 1;
- •Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
- •Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);
- •Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
- •Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
- •Known bleeding tendencies, including but not limited to platelet count <100×109/L; received heparin treatment within 48 hours with an activated partial thromboplastin time (APTT) ≥35s; recent oral anticoagulant therapy with international normalized ratio (INR) >3; Note: Patients without a history of coagulation abnormalities or without suspicion of coagulation abnormalities do not need to wait for laboratory test results before enrollment;
- •Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
- •Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
- •Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
- •Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
- •Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
- •Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
- •Aortic dissection;
- •Multiple intracranial large vessel occlusions confirmed by CTA or MRA, unable to clearly identify the symptomatic vessel, such as bilateral MCA occlusions or occlusions involving both the MCA and basilar artery;
- •Suspected or confirmed occluded artery is non-acute occlusion.
结局指标
主要结局
The rate of excellent outcome
时间窗: 90±7 days
mRS score 0-1
次要结局
- The rate of good outcome(90±7 days)
- mRS shift(90±7 days)
研究者
Wen-huo Chen
Professor
Zhangzhou Municipal Hospital
研究点 (9)
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