ERic Acute StrokE Recanalization (ERASER) (ERASER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02534701|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : October 10, 2017
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+).
|Condition or disease||Intervention/treatment|
|Ischemic Stroke||Device: ERIC® and SOFIA™|
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.
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||ERic Acute StrokE Recanalization (ERASER)|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||July 2017|
ERIC® and SOFIA™
ERIC® device in combination with SOFIA™ Distal Access Catheter
Device: ERIC® and SOFIA™
a self-expanding clot retrieval system
- VOST (volume of saved tissue) = VPIv- VMT [ Time Frame: 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
- mRS≤2 [ Time Frame: 90 days ]neurological outcomes (mRS≤2)
- NIHSS score improvement ≥10 from baseline [ Time Frame: 90 days ]neurological outcomes (NIHSS score improvement ≥10 from baseline)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534701
|Asklepios Klinik Altona|
|University Medical Center Hamburg-Eppendorf|
|Klinikum der Universität München|
|Principal Investigator:||Jens Fiehler, MD,PhD||Universitätsklinikum Hamburg-Eppendorf|