A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reperfusion rate (mTICI≥2b)
研究概览
简要总结
This is a multicenter, prospective registry clinical study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE device on the basis of standardised medical treatment.
详细描述
This is a multi-center, prospective, single-arm observational study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients using Revive SE device on the basis of standardised medical treatment.The device selection before treatment is based upon doctors who are blinded to the protocol. The primary outcomes are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90 days after intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 over 18 years;
- •clinical diagnosis should be acute ischaemic stroke;
- •no more than 6 hours after onset;
- •IV tPA thrombolysis, if needed, should start within 4.5 hours after onset；
- •Pre-stroke mRS ≤2;
- •ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;'
- •written informed consent form given
排除标准
- •. history of intracranial hemorrhage.
- •. life expectancy <90 days;
- •. history of major surgery or severe trauma in the past 10 days;
- •. Uncontrolled hypertension (defined as: SBP>185mmHg or DBP ≥110 mm Hg at 3 continuous measurements with interval of at least 10 minutes confirm the SBP>185mmHg or DBP ≥110 mm Hg)
- •. PLT<40*10^9/L；
- •. blood glucose <2.7mmol /L or >
- •. concomitant use of oral anticoagulation drugs, and INR >3.0；
- •. ASPECTS score ≤5；
- •. conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).
结局指标
主要结局
Reperfusion rate (mTICI≥2b)
时间窗: immediately after thrombectomy procedure
The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory
Functional outcome
时间窗: 3 months after thrombectomy procedure
the percentage of functional independence as assessed by mRS (modified Rankin Scale) score\<3
次要结局
- Number of passes of ReVive SE for each patient(within 3 hours after groin puncture)
- Procedure time(within 3 hours after groin puncture)
- Incidence of downstream embolization(within 3 hours after groin puncture)
- Incidence of embolization into new territories during intervention(within 3 hours after groin puncture)
- Incidence of symptomatic intracranial hemorrhage(within 24 hours after operation)
- Mortality(3 months)
- Device or intervention related adverse events(within 90 days after intervention)
研究者
Jian-min Liu
Department of Neurosurgery, Changhai hospital
Changhai Hospital