ERic Acute StrokE Recanalization (ERASER)

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: ERIC® and SOFIA™

• Registration Number: NCT02534701
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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+).

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Primary Completion: 2017-04
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERIC® and SOFIA™	ERIC® and SOFIA™	ERIC® device in combination with SOFIA™ Distal Access Catheter

Primary Outcome Measures

Name	Time	Method
VOST (volume of saved tissue) = VPIv- VMT	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

Name	Time	Method
mRS≤2	90 days	neurological outcomes (mRS≤2)
NIHSS score improvement ≥10 from baseline	90 days	neurological outcomes (NIHSS score improvement ≥10 from baseline)

Trial Locations

Locations (9)

Klinikum Dortmund; 🇩🇪 Dortmund, Germany

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Universität Greifswald; 🇩🇪 Greifswald, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Klinikum der Universität München; 🇩🇪 München, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany