NCT04310306Unknown不适用
First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- First Pass Recanalization (FPR) rate
研究概览
简要总结
This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3
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 or proximal M2 segment, intracranial vertebral artery and basilar artery
- •Age 19 or greater
- •mRS before qualifying stroke, 0 to 2
- •Baseline NIHSS score 4 or more
- •CT ASPECTS > 5 or MR ASPECTS > 4
- •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
- •Anticipated life expectancy of at least 12 months
- •Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
- •Signed informed consent for study enrollment
排除标准
- •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
First Pass Recanalization (FPR) rate
时间窗: Within 1 day after the completion of endovascular thrombectomyh
The rate of FPR defined by modified TICI 2b or 3
次要结局
- The rate of modified Rankin scale 0-2 at 3 months after treatment(90 days ± 14 days)
研究者
研究点 (1)
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