ERASER Study:
ERic Acute Stroke Recanalization
ERIC™ Stent Retriever
"ERASER is the first mechanical thrombectomy study with a primary end point based on predictive analytics enabling intraindividual virtual comparisons. The next-generation mechanical thrombectomy method resulted in smaller infarcts than predicted after intravenous tPA therapy alone and showed a high rate of good clinical outcome. The novel study design with virtual comparisons is promising for further application and testing in the neurovascular arena."
- Patients
81
- Countries
Germany & Switzerland
- Clinical Centers
9
- Design
Single arm prospective
- Scope
Patients ≥ 18 y.o. with acute ischemic stroke, NIHSS of 8-25, Intended usage of ERIC® as first device in combination with SOFIA™ Distal Access – Catheter (secondary bail-out with other devices allowed).
- Purpose
Assess the effect of ERIC™ device in combination with SOFIA™ Distal Access Catheter on artery recanalization and on clinical outcomes in stroke patients.
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+).
Endpoints
VOST (volume of saved tissue) = VPIv- VMT at 30 hours
(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)
Efficacy results
TICI 2b/3 : 95%
Median VOST: 50 mL at 30 hrs (smaller than predicted by the intravenous tPA therapy model)
Safety results
At 90 days:
mRS 0-2: 70%
Mortality : 9%
Study publications
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT02534701
SPONSOR: University Hospital Hamburg-Eppendorf
Please refer to Instruction for Use (IFU) in the specific market/country that you are looking into:
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