NCT02534701

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+).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

August 25, 2015

Last Update Submit

October 9, 2017

Conditions

Ischemic Stroke

Keywords

strokeclot retrieval systemrecanalization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • mRS≤2

    90 days

  • NIHSS score improvement ≥10 from baseline

    90 days

Study Arms (1)

ERIC® and SOFIA™

ERIC® device in combination with SOFIA™ Distal Access Catheter

Device: ERIC® and SOFIA™

Interventions

ERIC® and SOFIA™DEVICE

a self-expanding clot retrieval system

ERIC® and SOFIA™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 year with acute ischemic stroke

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Klinikum Dortmund

Dortmund, Germany

Location

Universität Greifswald

Greifswald, Germany

Location

Asklepios Klinik Altona

Hamburg, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Klinikum der Universität München

München, Germany

Location

Kantonspital Aarau

Aarau, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 31009356DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jens Fiehler, MD,PhD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 28, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(8)CH(1)