Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Modified Rankin Scale score
研究概览
简要总结
The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.
详细描述
Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular 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 (volume greater than 100 mL, ASPECTS score of 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.
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 or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
- •Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if > 6 hours or unknown last known well time;
- •Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
- •Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
- •The patient or patient's representative signs a written informed consent form.
排除标准
- •CT or MR evidence of hemorrhage;
- •Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
- •Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
- •History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- •Currently participating in another investigational drug study;
- •Any terminal illness with life expectancy less than 6 months.
研究组 & 干预措施
Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
干预措施: Medical management (Drug)
Endovascular thrombectomy
Patients in this group will be treated with medical management plus endovascular thrombectomy
干预措施: Endovascular thrombectomy (Procedure)
Medical management
Patients in this group will be treated with medical management alone
干预措施: Medical management (Drug)
结局指标
主要结局
Modified Rankin Scale score
时间窗: 90 days after randomization
Modified Rankin scale score (mRS): 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
次要结局
- Rate of successful reperfusion(Within 5 minutes at the end of angiogram)
- Rate of independent ambulation(90 days after randomization)
- Rate of excellent outcome(90 days after randomization)
- Rate of functional independence(90 days after randomization)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing