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+).
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.
- ERIC® and SOFIA™ Device
Intervention Desc: a self-expanding clot retrieval system ARM 1: Kind: Experimental Label: ERIC® and SOFIA™ Description: ERIC® device in combination with SOFIA™ Distal Access Catheter
- Observation: Cohort
- Perspective: Prospective
- Sampling: Non-Probability Sample
Patients over 18 year with acute ischemic stroke
|Type||Measure||Time Frame||Safety Issue|
|Primary||VOST (volume of saved tissue) = VPIv- VMT||30 h||No|
|Secondary||NIHSS score improvement ≥10 from baseline||90 days||No|