Ischemic StrokeERASERNCT02534701
ERic Acute StrokE Recanalization (ERASER)
An observational study of Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- ERIC® and SOFIA™
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 year with acute ischemic stroke
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Universitätsklinikum Augsburg
Augsburg
Klinikum Dortmund
Dortmund
Universität Greifswald
Greifswald
Asklepios Klinik Altona
Hamburg
University Medical Center Hamburg-Eppendorf
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
Universitätsklinikum Schleswig-Holstein
Lübeck
Klinikum der Universität München
München
About this study
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+).
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- ERIC® and SOFIA™
- Keywords
- stroke, clot retrieval system, recanalization
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERIC® and SOFIA™Device
a self-expanding clot retrieval system
| Study group | Role | What they receive |
|---|---|---|
| ERIC® and SOFIA™ | ERIC® device in combination with SOFIA™ Distal Access Catheter Receives: Device: ERIC® and SOFIA™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 h
Secondary outcomes (2)
mRS≤2
neurological outcomes (mRS≤2)
Measured: 90 days
NIHSS score improvement ≥10 from baseline
neurological outcomes (NIHSS score improvement ≥10 from baseline)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Fiehler, MD,PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534701
- Sponsor's protocol ID
- ERASER
- Acronym
- ERASER
- Status last verified
- Oct 2017
- First submitted
- 25 Aug 2015
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31009356
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERic Acute StrokE Recanalization (ERASER)
- ClinicalTrials.gov ID
- NCT02534701
- Acronym / sponsor ID
- ERASER / ERASER
- Conditions
- Ischemic Stroke
- Keywords
- stroke, clot retrieval system, recanalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERIC® and SOFIA™ | – | Device: ERIC® and SOFIA™ERIC® device in combination with SOFIA™ Distal Access Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 year with acute ischemic stroke
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERIC® and SOFIA™a self-expanding clot retrieval system | Device | ERIC® and SOFIA™ |
Primary outcome
VOST (volume of saved tissue) = VPIv- VMT
Time frame: 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
2 secondary outcomes
mRS≤2
Time frame: 90 days
NIHSS score improvement ≥10 from baseline
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Derived from this study: PubMed 31009356Fiehler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Fiehler, MD,PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOST (volume of saved tissue) = VPIv- VMT (time frame: 30 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.