Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2015-05-31
2017-07-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ERIC® and SOFIA™
ERIC® device in combination with SOFIA™ Distal Access Catheter
ERIC® and SOFIA™
a self-expanding clot retrieval system
Interventions
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ERIC® and SOFIA™
a self-expanding clot retrieval system
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre stroke mRS ≥ 2
* Necessity of ipsilateral internal carotid artery (ICA) angioplasty
* Age \<18 years
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Jens Fiehler, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Universitätsklinikum Augsburg
Augsburg, , Germany
Klinikum Dortmund
Dortmund, , Germany
Universität Greifswald
Greifswald, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum der Universität München
München, , Germany
Kantonspital Aarau
Aarau, , Switzerland
Countries
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References
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Fiehler J, Thomalla G, Bernhardt M, Kniep H, Berlis A, Dorn F, Eckert B, Kemmling A, Langner S, Remonda L, Reith W, Rohde S, Mohlenbruch M, Bendszus M, Forkert ND, Gellissen S. ERASER. Stroke. 2019 May;50(5):1275-1278. doi: 10.1161/STROKEAHA.119.024858.
Other Identifiers
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ERASER
Identifier Type: -
Identifier Source: org_study_id