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ERic Acute StrokE Recanalization (ERASER) (ERASER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02534701
First Posted: August 28, 2015
Last Update Posted: October 10, 2017
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.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose

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 Intervention
Ischemic Stroke Device: ERIC® and SOFIA™

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ERic Acute StrokE Recanalization (ERASER)

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 53
Actual Study Start Date: May 2015
Study Completion Date: July 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ERIC® and SOFIA™
ERIC® device in combination with SOFIA™ Distal Access Catheter
Device: ERIC® and SOFIA™
a self-expanding clot retrieval system

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 18 year with acute ischemic stroke
Criteria

Inclusion Criteria:

  • Acute ischemic stroke with NIH-SS score of 8-25
  • 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:

  • MCA >1/3 abnormal in DWI or CBV (ASPECTS ≤ 7, >100 mL)
  • Pre stroke mRS ≥ 2
  • Necessity of ipsilateral internal carotid artery (ICA) angioplasty
  • Age <18 years
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
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
Switzerland
Kantonspital Aarau
Aarau, Switzerland
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Jens Fiehler, MD,PhD Universitätsklinikum Hamburg-Eppendorf
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02534701     History of Changes
Other Study ID Numbers: ERASER
First Submitted: August 25, 2015
First Posted: August 28, 2015
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
clot retrieval system
recanalization

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases