NCT07347665招募中不适用
Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke With Occlusion of the M2 Segment of Middle Cerebral Artery (the Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism-M2 Occlusion Trial: RESCUE-M2O Trial)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2
研究概览
简要总结
RESCUE-M2O trial is a prospective, open label, blinded endpoint (PROBE), two-arm, randomized, controlled, post-market study to assess the efficacy and safety of endovascular therapy for acute ischemic stroke with occlusion of the M2 segment of the middle cerebral artery.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute cerebral infarction
- •Aged 18-84 years
- •NIHSS score at admission ≥ 8
- •Prestroke mRS scores of 0-1 (able to carry out all usual activities)
- •Occlusion of the M2 segment of MCA on digital subtraction angiography
- •ASPECTS ≥ 8 or DWI-ASPECTS ≥ 8
- •Ineligible or failed intravenous tPA (no recanalization within 30 min after injection)
- •Randomization can be completed within 24 h from the last known well time
- •EVT can be initiated within 30 min from randomization.
- •The patient or their legally authorized representative has signed the informed consent form.
排除标准
- •Occlusion of the anterior temporal artery, duplicate M1, or accessory M1
- •Occlusion of multiple major intracranial arteries
- •Difficulty in endovascular access due to tortuous vascular anatomy
- •Significant mass effect with midline shift on CT (or MRI)
- •Known allergy (more severe than skin rash) to contrast agents
- •Evidence of acute intracranial hemorrhage on CT (or MRI)
- •Pregnant or potentially pregnant
- •Clinical evidence of chronic occlusion
- •High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 sec or PT-INR > 3.0)
- •Participating in any other therapeutic investigational trial
- •Judgment of the investigator to be non-compliant or uncooperative during the study
研究组 & 干预措施
Medical therapy with endovascular therapy
Experimental
干预措施: Endovascular therapy (Procedure)
Medical therapy alone
No Intervention
结局指标
主要结局
Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-2
时间窗: 90 days after randomization
modified Rankin Scale (mRS) is an ordinal scale ranging from 0 (no symptoms) to 6 (death) measuring the degree of disability or dependence in everyday life.
次要结局
- Symptomatic intracranial hemorrhage(48 hours after randomization)
- Any intracranial hemorrhage(48 hours after randomization)
- All cause death(90 days after randomization)
- Recurrence of cerebral infarction(90 days after randomization)
- Decompressive craniectomy(7 days after randomization)
- Achievement of modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) scores of 0-1(90 days after randomization)
- modified Rankin Scale (mRS; range, 0-6; higher scores reflect worse functional outcome) shift analysis(90 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS; range, 0-42; higher scores indicate more severe neurological impairment) improvement of 8 points or more(48 hours after randomization)
- Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L; range, 0-1.0; higher scores indicating better health-related quality of life)(90 days after randomization)
研究者
Kazutaka Uchida
Associate Professor (Stroke Center)
Hyogo Medical University
研究点 (3)
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