NCT03993340已完成不适用
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- modified Rankin scale
研究概览
简要总结
This study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (ELVO) patients who have mechanical thrombectomy failure. Participants with ELVO will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. After failure of mechanical thrombectomy, rescue stenting will be performed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
- •Age 19 or greater
- •mRS before qualifying stroke, 0 or 1
- •Baseline NIHSS score 4 or more
- •CT ASPECTS > 6 or MR ASPECTS > 5
- •Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
- •Onset (last-seen-well) time to femoral puncture time < 24 hours
- •Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
- •Subjects who received rescue stenting after failure of mechanical thrombectomy
- •Anticipated life expectancy of at least 12 months
- •Signed informed consent for study enrollment
排除标准
- •Any contraindication to antiplatelet medication
- •Multiple simultaneous large vessel occlusions
- •Severe contrast allergy or absolute contraindication to iodinated contrast agent
- •Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
结局指标
主要结局
modified Rankin scale
时间窗: 3 months
The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2
次要结局
- Patency of the target artery(1 day to 28 days)
研究者
研究点 (1)
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