Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)

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.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: EmboTrap® Revascularization Device

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
• Germany
  • Kiel, Germany
    • Universitätsklinikum Kiel
• Ireland
  • Dublin, Ireland
    • Beaumont Hospital
• Spain
  • Barcelona, Spain
    • Hospital Clínico de Barcelona
• Sweden
  • Solna, Sweden, 17176
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ischemic stroke patients

Description

Inclusion Criteria:

• 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.
• 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:

  1. MRI criterion: ASPECTS 8 to 10, or,volume of diffusion restriction ≤30 mL and mismatch between perfusion reduction and diffusion restriction present.
  2. 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EmboTrap® Revascularization Device; The EmboTrap® Revascularization Device is the investigational device	Device: EmboTrap® Revascularization Device; Other Names: EmboTrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Revascularization	Defined as time from groin puncture to visualization of final angiographic result.	Day 1
Mortality Post Procedure	All procedure related mortality (i.e. directly traceable to a procedure related SAE).	7 and 90(±14) days post procedure
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.	24(-8/+12) hours Post Procedure
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.	24(-8/+12) hours Post Procedure
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.	90(±14) days Post Procedure
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.	24(-8/+12) hours Post Procedure
Evidence of Infarction	Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.	24(-8/+12) hours Post Procedure

Collaborators and Investigators

• Sponsor: Neuravi Limited
• Investigators: Principal Investigator: Dr. Tommy Andersson, Karolinska Institutet; Principal Investigator: Prof. Dr. Heinrich Mattle, University Hospital Inselspital, Berne

Publications and helpful links

General 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.

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Stroke; Vascular Diseases; Ischemic; Revascularization; Ischemia; Brain; Ischemic Stroke; Brain Diseases; Cerebrovascular Disorders; Brain Infarction; Cerebral Ischemia; Brain Clot; EmboTrap® Revascularization Device; EmboTrap; Mechanical Thrombectomy; Neurovascular Intervention; Stent Retriever
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: CIP001