The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- First-pass complete recanalization rate
研究概览
简要总结
This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.
详细描述
AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
- •Premorbid mRS 0-2
- •Ages 18-80 years
- •NIHSS ≥6 at admission
- •The time from onset to groin puncture ≤ 24 hours
- •ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)
- •Informed consent approved by patients or acceptable patient surrogate.
排除标准
- •Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory).
- •Severe allergy to contrast media allergy and nitinol
- •Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- •Platelet count < 30 x 10^9 / L
- •Coagulopathy history or hemorrhage disorders disease
- •Concurrent participation in a study involving an investigational drug or device that would impact the current study
- •Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
- •Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders
- •Pregnant or lactating women
- •Anticipated life expectancy < 6 months
- •Patients without a legally authorized representative to sign the consent form
- •For other reasons, the researchers believe that the patient is not suitable for enrollment
结局指标
主要结局
First-pass complete recanalization rate
时间窗: intraoperative (After first-pass thrombectomy)
FPE, eTICI≥2c
次要结局
- 90-day favorable outcome rate(90-days (±14days))
- Final complete recanalization rate(intraoperative (Final Digital Subtraction Angiography (DSA) during operation))
- The improvement of the NIHSS scores 24 hours after surgery(24 hours after surgery)
- The rescue therapy rate(During procedure time)
- Final successful recanalization rate(intraoperative (Final Digital Subtraction Angiography (DSA) during operation))
- First-pass successful recanalization rate(intraoperative (After first-pass thrombectomy))
- The improvement of the NIHSS scores 5-7 days after surgery or at discharge(5-7 days after surgery or at discharge, whichever came first)
- FFR after 5 minutes of mechanical thrombectomy(5 minutes after successful vessel recanalization.)