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 Type
OBSERVATIONAL
Enrollment
40
Aarhus University Hospital
Aarhus, Denmark
Universitätsklinikum Kiel
Kiel, Germany
Beaumont Hospital
Dublin, Ireland
Hospital Clinico de Barcelona
Barcelona, Spain
Karolinska Institutet
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
Time frame: Day 1
Time to Revascularization
Defined as time from groin puncture to visualization of final angiographic result.
Time frame: Day 1
Mortality Post Procedure
All procedure related mortality (i.e. directly traceable to a procedure related SAE).
Time frame: 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.
Time frame: 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.
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Solna, Sweden
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24(-8/+12) hours Post Procedure