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Ischemic StrokeARISENCT02190552

Analysis of Revascularisation in Ischemic Stroke With EmboTrap

An observational study of Ischemic Stroke, run by Neuravi Limited at 5 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A.R.I.S.E. is a post approval observational study using standard care. The purpose of this study is to collect information about the ability of the EmboTrap device to remove blood clots from the brain, and the associated performance characteristics and clinical outcomes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
EmboTrap® Revascularization Device
Type of treatment
Medical device
How many people
40 participants
Where
5 sitesin 5 countries
Study dates
Nov 2014to Jan 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Ischemic stroke patients

Who may be able to join

  • The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
  • Aged between 18 years and 80 years (inclusive).
  • A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  • NIHSS score ≥8 and ≤25.
  • Pre-ictal mRS score of 0 or 1.
  • Angiographic confirmation of an occlusion of an ICA (including T and L occlusions), M1 or M2, MCA, or BA with TICI flow of 0-1.
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  • Confirmation by the interventionalist, after screening CT or MRI, that the treatment site can be accessed with the Neuravi device.
  • The interventionalist estimates that at least one deployment of the Neuravi device can be completed within 5 hours from the onset of symptoms, or if time of onset of symptoms is unknown or > 5 hours, patients can be included using imaging with the following criteria:
  • MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
  • CT criterion: ASPECTS 8 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤30 mL and mismatch between perfusion reduction and low CBV present.

Who cannot join

  • Life expectancy of less than 6 months.
  • Females who are pregnant or lactating.
  • History of severe allergy to contrast medium.
  • Has suffered a stroke in the past three months.
  • The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
  • Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0.
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  • Platelet count < 50,000.
  • Glucose < 50 mg/dL.
  • Heparin use in previous 24 hours with PTT or ACT > 2X normal.
  • Any known hemorrhagic or coagulation deficiency.
  • Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
  • For basilar artery occlusion, extended early ischemic changes as confirmed by pc-ASPECTS ≤ 7 on baseline CT or CTA-source images, or extensive DWI lesions in the midbrain or pons regions on pre-treatment MRI.
  • Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma).
  • Excessive arterial tortuosity that precludes the study device from reaching the target vessel.
  • A proximal stenosis or complete occlusion that cannot, as judged by the responsible interventionalist, be treated safely or which prevents access to the occluded vessel with the Neuravi device.
  • Evidence of active infection.
  • Known cancer with metastases
  • Current use of cocaine or other vasoactive substance.

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

Denmark1 site

  • Aarhus University Hospital

    Aarhus

Other trials in Denmark

Germany1 site

  • Universitätsklinikum Kiel

    Kiel

Other trials in Germany

Ireland1 site

  • Beaumont Hospital

    Dublin

Other trials in Ireland

Spain1 site

  • Hospital Clinico de Barcelona

    Barcelona

Other trials in Spain

Sweden1 site

  • Karolinska Institutet

    Solna, 17176

Other trials in Sweden

About this study

Official title: A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device

A.R.I.S.E. is a post approval observational study using standard care. The purpose of this study is to collect information about the ability of the EmboTrap device to remove blood clots from the brain, and the associated performance characteristics and clinical outcomes. No formal hypothesis testing is needed as no comparisons are planned within the study. Instead, estimates of each population parameter of interest for all primary and secondary endpoints will be provided using appropriate confidence intervals.

Conditions
Ischemic Stroke
Being tested
EmboTrap® Revascularization Device
Keywords
Brain, Brain Clot, Brain Diseases, Brain Infarction, Cerebral Ischemia, Cerebrovascular Disorders, EmboTrap® Revascularization Device, EmboTrap, Ischemia, Ischemic, Ischemic Stroke, Mechanical Thrombectomy, Neurovascular Intervention, Revascularization, Stent Retriever, Stroke, Vascular Diseases
Medical subject headings
Ischemic Stroke, Brain Diseases, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Ischemia, Stroke, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmboTrap® Revascularization DeviceDevice

    Also called EmboTrap

Study groups in NCT02190552
Study groupRoleWhat they receive
EmboTrap® Revascularization DeviceThe EmboTrap® Revascularization Device is the investigational device
Receives: Device: EmboTrap® Revascularization Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Revascularisation Following the Use of the Neuravi Device.

    Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:

    mTICI 0 = No perfusion

    mTICI 1 = Penetration but not perfusion

    mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized

    mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized

    mTICI 2c = Near-complete perfusion

    mTICI 3 = Complete perfusion

    Measured: Day 1

Secondary outcomes (7)

  1. Time to Revascularization

    Defined as time from groin puncture to visualization of final angiographic result.

    Measured: Day 1

  2. Mortality Post Procedure

    All procedure related mortality (i.e. directly traceable to a procedure related SAE).

    Measured: 7 and 90(±14) days post procedure

  3. Serious Adverse Device Related Effects (SADE)

    SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.

    Measured: 24(-8/+12) hours Post Procedure

  4. Symptomatic ICH

    Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.

    The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.

    Measured: 24(-8/+12) hours Post Procedure

  5. Clinical Outcome at 90 Days

    A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:

    mRS 0 = No symptoms.

    mRS 1 = No significant disability.

    mRS 2 = Slight disability.

    mRS 3 = Moderate disability.

    mRS 4 = Moderately severe disability.

    mRS 5 = Severe disability.

    mRS 6 = Dead.

    Measured: 90(±14) days Post Procedure

  6. Rate of New Territory Embolization

    Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.

    Measured: 24(-8/+12) hours Post Procedure

  7. Evidence of Infarction

    Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.

    Measured: 24(-8/+12) hours Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionMay 2016
  4. Study completionJan 2018

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02190552
Sponsor's protocol ID
CIP001
Acronym
ARISE
Status last verified
Nov 2018
First submitted
10 Jul 2014
Last updated
11 Mar 2019
Data monitoring committee
Yes

Publications

  • Mattle HP, Scarrott C, Claffey M, Thornton J, Macho J, Riedel C, Soderman M, Bonafe A, Piotin M, Newell J, Andersson T; ARISE I Study Group. Analysis of revascularisation in ischaemic stroke with EmboTrap (ARISE I study) and meta-analysis of thrombectomy. Interv Neuroradiol. 2019 Jun;25(3):261-270. doi: 10.1177/1591019918817406. Epub 2018 Dec 18.

    PubMed 30563388

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Neuravi Limited at 5 sites in 5 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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark, Germany, Ireland, Spain, Sweden. 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?

Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Revascularisation Following the Use of the Neuravi Device. (time frame: Day 1). 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 NCT02190552, 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 11 Mar 2019.

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