ERic Acute StrokE Recanalization (ERASER) | NCT02534701

Studies
ERic Acute StrokE Recanalization (ERASER)

NCT02534701

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Oct 10, 2017Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

ERIC® and SOFIA™

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Aug 25, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Aug 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2017

Last Update Posted Date

Oct 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ERIC® and SOFIA™		ERIC® device in combination with SOFIA™ Distal Access Catheter	Device: ERIC® and SOFIA™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERIC® and SOFIA™	Device	a self-expanding clot retrieval system	ERIC® and SOFIA™

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 year with acute ischemic stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Fiehler, MD,PhD	Universitätsklinikum Hamburg-Eppendorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Augsburg		Augsburg			Germany
Klinikum Dortmund

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31009356	Derived	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke