Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- modified Rankin Scale ≤3 at 90 days
研究概览
简要总结
RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5).
The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).
详细描述
In the American Heart Association guideline 2018, endovascular therapy (EVT) has been strongly recommended as class of recommendation (COR) I for for the patients with acute cerebral large vessel occlusion (LVO), the Alberta Stroke Program Early CT Score (ASPECTS) 6 or more. The efficacy of EVT for the patients with low ASPECTS remains unclear.
This study is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone for acute large vessel occlusion patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTS 3-5).
Up to 200 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by treatment institutes, patient's age (less than 75 years old or not), time from symptom onset (0-2 hours or more than 2 hours), and stroke severity (NIHSS 21 or more/less than 21), and administration of rt-PA.
Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm 1: best medical treatment Arm 2: best medical treatment plus endovascular treatment
Primary outcome of this study is to investigate efficacy of endivascular treatment in acute stroke patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTs 3-5) as compared to best medical treatment alone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute cerebral infarction
- •Prestroke Modified Rankin Score 0-1
- •ICA or M1 Occlusion on CT angiography or MR angiography
- •ASPECTS 3-5 or DWI-ASPECTS 3-5
- •Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.
- •Endovascular treatment can be initiatedwithin 60 minutes from randomization
- •Patient or Legally Authorized Representative has signed the Informed Consent form
排除标准
- •Significant mass effect with midline shift
- •Known allergy to contrast agents
- •Evidence of acute intracranial hemorrhage
- •Female who is pregnant or suspicision of pregnant
- •Clinical evidence of chronic occlusion
- •High risk of hemorrhage (platelet < 40,000 /µL, APTT > 50 second or PT-INR > 3.0)
- •Participating in any other therapeutic investigational trial
- •Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
结局指标
主要结局
modified Rankin Scale ≤3 at 90 days
时间窗: 90 days
The primary endpoint of the trial is the modified Rankin Scale (mRS) ≤3 at 90 days post-stroke.The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death. 0: No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own a 符 airs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and a 悦 ention, bedridden, incontinent. 6. Dead.
次要结局
- NIHSS improvement 8 points or more at 48 hours(48 hours)
- modified Rankin Scale≤2 at 90 days(90 days)
- modified Rankin Scale≤1 at 90 days(90 days)
- Death(90 days)
- Recurrence of cerebral infarction within 90 days(90 days)
- Propotion of subjects who required decompressive craniectomy within 7 days(7 days)
- Symptomatic intracranial hemorrhage within 48 hours(48 hours)
- Intracranial hemorrhage within 48 hours(48 hours)
- Distribution of patients across the ordinal modified Rankin scale(90 days)
研究者
Shinichi Yoshimura
Department of Neurosurgery
Hyogo Medical University