An Investigator Initiated and Conducted, Prospective, Multicenter, Randomized Outcome-blinded Study of Treating Mechanical Thrombectomy Exceeding 24 Hours in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lili SONG
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Functional recovery (level of disability)
研究概览
简要总结
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
详细描述
The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; Barthel Index; and hospital service costs.
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
- •Present 24-72 hours of stroke onset or last seen well
- •Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging
- •National Institute of Health stroke scale (NIHSS) ≥6 at randomisation
- •Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume <50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL
- •Written informed consent (by patient or proxy, according to local requirements)
排除标准
- •Clinical Exclusion Criteria
- •Considered unlikely to benefit from trial (e.g. advanced dementia, major pre-stroke disability (prior modified Rankins scale (mRS) ≥2), high likelihood of early death), as judged by the responsible treating clinician
- •Major co-morbid disease that could interfere with outcome assessments and follow-up (e.g. cancer, severe heart failure, kidney failure)
- •Unable to undergo a CTP
- •Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure
- •Seizures at stroke onset or before randomization and baseline NIHSS scores cannot be accurately determined
- •Baseline blood glucose of <50 mg/dL (2.78 mmol/L) or >400 mg/dL (22.20 mmol/L)
- •Baseline platelet count < 50,000/uL
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with International normalized ratio (INR) >3
- •Severe, sustained hypertension that can not be controlled by medication (systolic BP >220 mmHg or diastolic BP >120 mmHg)
- •Presumed septic embolus, suspicion of bacterial endocarditis
- •EVT attempted after stroke onset
- •Unlikely to participate in follow-up assessments
- •Currently participating in another trial that may affect outcomes.
- •Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
- •Neuroimaging Exclusion Criteria
- •Intracranial hemorrhage (ICH), including parenchymal hemorrhage, ventricular hemorrhage, subarachnoid hemorrhage, and subdural/exsanguination
- •Evidence of intracranial malignant tumor
- •Significant mass effect with midline shift
- •Aortic dissection
- •Intracranial stent implanted in the same vascular territory
- •Any other condition that may affect EVT procedure, like the tortuous vascular path the device is difficult to reach the target position or difficult to recover
- •Occlusions in multiple vascular territories confirmed on Computerized tomography angiography (CTA)/ Magnetic resonance imaging angiography (MRA) (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
研究组 & 干预措施
Intervention group
Mechanical thrombectomy to be initiated as soon as possible after randomisation.
干预措施: Mechanical thrombectomy (Procedure)
Control group
Patients assigned to the control group will avoid treating MT and only receive the standard medical treatment according to local guidelines.
结局指标
主要结局
Functional recovery (level of disability)
时间窗: at 90 days
A sequence shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome.
次要结局
- Death(within 90 days)
- Neurological function(at 24 hours and 7 days)
- Death or major disability(at 90 days)
- Major disability(at 90 days)
- Utility-weighted modified Rankin scale scores(at 90 days)
- Health-related Quality of Life (HRQoL)(at 90 days)
- Barthel Index(at 90 days)
- Infarct volume(at 7 days)
- Recanalization(at 48 hours)
研究者
Lili SONG
Professor and Executive Director, Institute of Science and Technology for Brain-inspired Intelligence
Fudan University