ERic Acute StrokE Recanalization (ERASER) "ERASER"

Completed

Phase N/A Results N/A

Update History

11 Oct '17
The Summary of Purpose was updated.
New
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+).
Old
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+).
The description was updated.
New
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.
Old
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.
26 May '17
The gender criteria for eligibility was updated to "All."
A location was updated in Augsburg.
New
The overall status was removed for Universitätsklinikum Augsburg.
A location was updated in Dortmund.
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The overall status was removed for Klinikum Dortmund.
A location was updated in Greifswald.
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The overall status was removed for Universität Greifswald.
A location was updated in Hamburg.
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The overall status was removed for Asklepios Klinik Altona.
A location was updated in Hamburg.
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The overall status was removed for University Medical Center Hamburg-Eppendorf.
A location was updated in Heidelberg.
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The overall status was removed for Universitätsklinikum Heidelberg.
A location was updated in Homburg.
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The overall status was removed for Universitätsklinikum des Saarlandes.
A location was updated in Lübeck.
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The overall status was removed for Universitätsklinikum Schleswig-Holstein.
A location was updated in München.
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The overall status was removed for Klinikum der Universität München.
A location was updated in Aarau.
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The overall status was removed for Kantonspital Aarau.
9 Sep '16
A location was updated in Dortmund.
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The overall status was removed for Klinikum Dortmund.
A location was updated in Heidelberg.
New
The overall status was removed for Universitätsklinikum Heidelberg.
A location was updated in Homburg.
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The overall status was removed for Universitätsklinikum des Saarlandes.
A location was updated in Köln.
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The overall status was updated to "Recruiting" at Universitätsklinikum Köln.