ERic Acute StrokE Recanalization (ERASER) (ERASER)

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+).

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: ERIC® and SOFIA™

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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Universitätsklinikum Augsburg
  • Dortmund, Germany
    • Klinikum Dortmund
  • Greifswald, Germany
    • Universitat Greifswald
  • Hamburg, Germany
    • University Medical Center Hamburg-Eppendorf
  • Hamburg, Germany
    • Asklepios Klinik Altona
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Lübeck, Germany
    • UNIVERSITÄTSKLINIKUM Schleswig-Holstein
  • München, Germany
    • Klinikum der Universität München
• Switzerland
  • Aarau, Switzerland
    • Kantonspital Aarau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 year with acute ischemic stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERIC® and SOFIA™; ERIC® device in combination with SOFIA™ Distal Access Catheter	Device: ERIC® and SOFIA™; a self-expanding clot retrieval system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VOST (volume of saved tissue) = VPIv- VMT	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	30 h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS≤2	neurological outcomes (mRS≤2)	90 days
NIHSS score improvement ≥10 from baseline	neurological outcomes (NIHSS score improvement ≥10 from baseline)	90 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Jens Fiehler, MD,PhD, Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: stroke; recanalization; clot retrieval system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ERASER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO