XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale score
研究概览
简要总结
Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT [Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core], LASTE [LArge Stroke Therapy Evaluation], RESCUE-Japan LIMIT [The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial], SELECT 2 [Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke], and TENSION [The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score [ASPECTS] ≥3 or infarct core <100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Clinical inclusion criteria
- •Age ≥18 years;
- •Presenting with acute ischemic stroke within 24 hours of time from last known well;
- •The patient or patient's representative signs a written informed consent form before enrollment.
- •Neuroimaging inclusion criteria
- •Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;
- •The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow <30% on CT perfusion or an apparent diffusion coefficient <620×10^-6 mm2/s on MRI).
- •Exclusion criteria
- •CT or MRI evidence of acute intracranial hemorrhage;
- •Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
- •Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
- •Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- •Any terminal illness with life expectancy less than 6 months;
- •Participation in other clinical treatment trials.
排除标准
- 未提供
结局指标
主要结局
Modified Rankin Scale score
时间窗: 90±14 days after enrollment
The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).
次要结局
- Independent ambulation(90±14 days after enrollment)
- Not ambulatory nor capable of body self-care(90±14 days after enrollment)
- Excellent outcome(90±14 days after enrollment)
- Functional independence(90±14 days after enrollment)
- Mortality during hospitalization(7 days after enrollment)
- National Institutes of Health Stroke Scale score(5-7 days after enrollment or discharge (whichever occurred first))
- Health-related quality of life(90±14 days after enrollment)
- Incidence of symptomatic intracranial hemorrhage(48 hours after enrollment)
- Incidence of any intracranial hemorrhage(48 hours after enrollment)
- Incidence of decompressive hemicraniectomy(7 days after enrollment)
- Mortality(90±14 days after enrollment)
- Mortality within 1 year(One year after enrollment)
- The occurrence of non-hemorrhagic serious adverse events(through study completion, an average of 90 days)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing