ERic Acute StrokE Recanalization (ERASER)

Ischemic Stroke Clinical Trial

— ERASER  

Official title:

ERic Acute StrokE Recanalization (ERASER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534701
• Other study ID #: ERASER
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: October 9, 2017
• Start date: May 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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+).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• ERIC® and SOFIA™
a self-expanding clot retrieval system

Locations

Country	Name	City	State
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
Switzerland	Kantonspital Aarau	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mRS=2	neurological outcomes (mRS=2)	90 days
Secondary	NIHSS score improvement =10 from baseline	neurological outcomes (NIHSS score improvement =10 from baseline)	90 days