NCT06580730尚未招募不适用
Endovascular Treatment Post 1 Day （24 Hours）: a Randomized Controlled Clinical Trial on Efficacy and Safety for Stroke
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
研究概览
简要总结
Acute ischemic stroke (AIS) is one of the leading causes of disability and mortality worldwide. The treatment of this condition is time-critical, with the key to effective therapy being the early recanalization of the occluded vessel and restoration of blood flow to salvage the ischemic penumbra tissue. Currently, the time window for endovascular treatment in the anterior circulation can be extended up to 24 hours. Exploring endovascular treatments for patients beyond this time window (from 24 hours to 30 days) could mean hope for a greater number of AIS patients.
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
- None
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
- •General Inclusion Criteria
- •Age≥18 and ≤80
- •Baseline NIHSS ≥ 6 and maintained ≥ 6 before randomization
- •Stroke onset or more than 24 hours from the last known well state and within 30 days.
- •Pre-stroke mRS score of 0 or 1 points
- •The subject or their legally authorized representative has signed the informed consent form for the study
- •Imaging Inclusion Criteria
- •Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA), or Digital Subtraction Angiography (DSA) confirms the occlusion of major intracranial vessels (occlusion of the internal carotid artery and/or the middle cerebral artery M1/M2 segment)
- •Meets one of the following imaging evaluation criteria:
- •Assessed by Computed Tomography Perfusion (CTP) or Perfusion Weighted Imaging (PWI) with MRI: Infarct core volume is less than 100 mL and the mismatch ratio is ≥1.2 or the mismatch volume is ≥10 mL.
- •Clinical imaging mismatch is defined by MR-DWI or CTP-rCBF images as:
- •Infarct volume is less than 30 mL and NIHSS score is ≥10;
- •Infarct volume is between 30 mL and 100 mL and NIHSS score is ≥20
排除标准
- •General Exclusion Criteria
- •In the judgment of the clinician responsible for treatment, it is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥2), high likelihood of early death)
- •Major comorbidities that may interfere with the assessment of results and follow-up (e.g., severe heart failure, renal failure, etc.)
- •Rapid improvement in neurologic status to NIHSS<6 or evidence of vascular reconstruction before randomization
- •Uncontrolled seizures at the time of stroke onset that, if preventing the acquisition of an accurate baseline NIHSS
- •Baseline platelet count<50,000/uL
- •Severe persistent hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure>120 mmHg)
- •Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) >3
- •Suspected septic emboli, suspected bacterial endocarditis
- •Known allergy to iodine, heparin, anesthetics, or other clear contraindications to the endovascular treatment procedure
- •Pregnant women
- •Other serious, progressive, or terminal illnesses (as judged by the investigator) or life expectancy of less than 6 months
- •Attempt to use a neurothrombectomy device to remove the blood clot before randomization
- •Currently participating in other studies of investigational drugs or devices
- •Any other conditions that, in the opinion of the investigator, would impede endovascular surgery or pose a significant risk to the subject during endovascular surgery
- •Imaging Exclusion Criteria
- •Intracranial hemorrhage, including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and epidural/subdural hemorrhage;
- •Evidence of intracranial tumors as shown by CT or MRI (except for small meningiomas);
- •CTA/MRA showing excessive tortuosity of the cervical vessels, which may hinder endovascular treatment;
- •Suspected aortic dissection based on medical history and CTA/MRA;
- •Presence of an intracranial stent in the same vascular area, which would impede the smooth progress of surgery.
结局指标
主要结局
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
时间窗: 90days
Modified Rankin Scale：1. Total asymptomatic score 0 2, despite symptoms, but no obvious dysfunction, can complete all daily work and life score 1 Mildly disabled, unable to complete all pre-illness activities, but able to take care of daily tasks without assistance score 2 3, moderate disability, need some help, but can walk independently score 3 4, moderate to severe disability, can not walk independently, daily life needs help from others score 4 5, severe disability, bed rest, urinary incontinence, daily life completely dependent on others score 5 6. Death score 6
次要结局
- Proportion of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence(90days)
- New stroke or TIA within 90 days(90days)
- For the treatment group only: Assessment of cerebral collateral circulation in ischemic stroke(Post procedure 24hours)
- Sustained vessel recanalization rate at 90 days(90days)
- Proportion with "early improvement" between day 2-7 post-randomization/discharge(2-7days)
- Difference in median infarct volume size at 24 (-6/+24) hours post-randomization(24hours)
- All-cause mortality at 90 days(90days)
- For the treatment group only: Analysis of post-procedure vascular reperfusion rate (percentage)(Post procedure 24hours)
- Assessment of activities of daily living at 90 days(90days)
- Vessel recanalization at 24 (-6/+24) hours post-randomization(24hours)
- Montreal Cognitive Assessment (MoCA) score at 90 days(90days)
- Substantial hematoma type 2 within 24 (-6/+24) hours post-randomization(24hours)
- EQ-5D-5L questionnaire score at 90 days(90days)
- Stroke-related mortality at 90 days(90days)
- Symptomatic intracranial hemorrhage (sICH)(24hours)
- Mini-Mental State Examination (MMSE) score at 90 days(90days)
- Neurological deterioration(2-7days)
- Procedure-related complications(Post procedure 24hours)
研究者
Hu Bo
Doctor
Wuhan Union Hospital, China
研究点 (1)
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