ERic Acute StrokE Recanalization (ERASER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 9
- 主要终点
- VOST (volume of saved tissue) = VPIv- VMT
研究概览
简要总结
To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on artery recanalization and on clinical outcomes in stroke patients using data from clinical routine application (ERASER).
To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on the final infarct volume as determined by advanced image postprocessing methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).
详细描述
This is a prospective, international, single-arm, controlled, open label post-market, multicenter study to compare the safety and effectiveness of ERIC® device in combination with SOFIA™ Distal Access Catheter in acute ischemic stroke patients using clinical routine data.
Patients who meet the imaging inclusion criteria for ERASER will be included in the cohort where collected and additionally analyzed data will be compared to a historical patient cohort (referred to as ERASER imaging =ERASER+). All other patients will be included in a registry (referred to as ERASER), where clinical information will be collected. The overall study duration is expected to be 18 Months. The expected duration of each subject's enrolment is approximately 90 days. Subjects will be followed with assessments at 90 days post stroke.
The basic concept of ERASER+ is the use an infarct prediction algorithm that has been trained on a large dataset of historical imaging data of patients treated with IV tPA, apply it to the pre-treatment imaging and compare its predictions with the actual outcome.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke with NIH-SS score of 8-25
- •CTP/ MRP <4.5h after symptom onset completed
- •CTA/ MRA confirms M1-occlusion
- •Groin puncture estimated <6h after stroke onset
- •Intended usage of ERIC® as first device in combination with SOFIA™ Distal Access -Catheter (secondary bail-out with other devices allowed)
排除标准
- •MCA >1/3 abnormal in DWI or CBV (ASPECTS ≤ 7, >100 mL)
- •Pre stroke mRS ≥ 2
- •Necessity of ipsilateral internal carotid artery (ICA) angioplasty
- •Age <18 years
结局指标
主要结局
VOST (volume of saved tissue) = VPIv- VMT
时间窗: 30 h
volume of saved tissue (VOST) as difference of the brain volume with an infarct risk of \>50%, based on a prediction- algorithm trained in a historical cohort treated with IV tPA (VPIv) and the actual infarct volume
次要结局
- mRS≤2(90 days)
- NIHSS score improvement ≥10 from baseline(90 days)