ERic Acute StrokE Recanalization (ERASER)

Study Overview
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Brief Summary
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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+).

Detailed Description
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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.

Official Title
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ERic Acute StrokE Recanalization (ERASER)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: ERIC® and SOFIA™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERIC® and SOFIA™<br>ERIC® device in combination with SOFIA™ Distal Access Catheter | Device: ERIC® and SOFIA™<br>* a self-expanding clot retrieval system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VOST (volume of saved tissue) = VPIv- VMT | 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 | 30 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS≤2 | neurological outcomes (mRS≤2) | 90 days | 
| NIHSS score improvement ≥10 from baseline | neurological outcomes (NIHSS score improvement ≥10 from baseline) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, clot retrieval system, recanalization