Ischemic Stroke
Conditions
Keywords
stroke, clot retrieval system, recanalization
Brief summary
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
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.
Interventions
DEVICEERIC® and SOFIA™
a self-expanding clot retrieval system
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VOST (volume of saved tissue) = VPIv- VMT | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS≤2 | 90 days | neurological outcomes (mRS≤2) |
| NIHSS score improvement ≥10 from baseline | 90 days | neurological outcomes (NIHSS score improvement ≥10 from baseline) |
Countries
Germany, Switzerland
Outcome results
None listed