A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Proportion of Revascularisation Following the Use of the Neuravi Device.
研究概览
简要总结
A.R.I.S.E. is a post approval observational study using standard care. The purpose of this study is to collect information about the ability of the EmboTrap device to remove blood clots from the brain, and the associated performance characteristics and clinical outcomes. No formal hypothesis testing is needed as no comparisons are planned within the study. Instead, estimates of each population parameter of interest for all primary and secondary endpoints will be provided using appropriate confidence intervals.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- •Aged between 18 years and 80 years (inclusive).
- •A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- •NIHSS score ≥8 and ≤
- •Pre-ictal mRS score of 0 or
- •Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1 or M2, MCA, or BA with TICI flow of 0-
- •Confirmation by the interventionalist, after screening CT or MRI, that the treatment site can be accessed with the Neuravi device.
- •The interventionalist estimates that at least one deployment of the Neuravi device can be completed within 5 hours from the onset of symptoms, or if time of onset of symptoms is unknown or > 5 hours, patients can be included using imaging with the following criteria:
- •MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
- •CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low CBV present.
排除标准
- •Life expectancy of less than 6 months.
- •Females who are pregnant or lactating.
- •History of severe allergy to contrast medium.
- •Has suffered a stroke in the past three months.
- •The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- •Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.
- •Platelet count < 50,
- •Glucose < 50 mg/dL.
- •Heparin use in previous 24 hours with PTT or ACT > 2X normal.
- •Any known hemorrhagic or coagulation deficiency.
- •Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- •For basilar artery occlusion, extended early ischemic changes as confirmed by pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the midbrain or pons regions on pre-treatment MRI.
- •Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma).
- •Excessive arterial tortuosity that precludes the study device from reaching the target vessel.
- •A proximal stenosis or complete occlusion that cannot, as judged by the responsible interventionalist, be treated safely or which prevents access to the occluded vessel with the Neuravi device.
- •Evidence of active infection.
- •Known cancer with metastases
- •Current use of cocaine or other vasoactive substance.
结局指标
主要结局
Proportion of Revascularisation Following the Use of the Neuravi Device.
时间窗: Day 1
Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater. mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion mTICI 1 = Penetration but not perfusion mTICI 2a = Some perfusion with distal branch filling of \<50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized mTICI 2c = Near-complete perfusion mTICI 3 = Complete perfusion
次要结局
- Rate of New Territory Embolization(24(-8/+12) hours Post Procedure)
- Clinical Outcome at 90 Days(90(±14) days Post Procedure)
- Time to Revascularization(Day 1)
- Mortality Post Procedure(7 and 90(±14) days post procedure)
- Serious Adverse Device Related Effects (SADE)(24(-8/+12) hours Post Procedure)
- Evidence of Infarction(24(-8/+12) hours Post Procedure)
- Symptomatic ICH(24(-8/+12) hours Post Procedure)