Clinical trial NCT02534701: ERic Acute StrokE Recanalization (ERASER)
Official title: ERic Acute StrokE Recanalization (ERASER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
clot retrieval system
recanalization
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 year with acute ischemic stroke

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.

Eligibility 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

Primary outcomes:
measure: VOST (volume of saved tissue) = VPIv- VMT
timeFrame: 30 h
Secondary outcomes:
measure: mRS≤2
timeFrame: 90 days
measure: NIHSS score improvement ≥10 from baseline
timeFrame: 90 days
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Greifswald
country: Germany
facility: Universität Greifswald
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: München
country: Germany
facility: Klinikum der Universität München
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jens Fiehler, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.