Analysis of Revascularisation in Ischemic Stroke With EmboTrap

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: EmboTrap® Revascularization Device


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EmboTrap® Revascularization Device<br>The EmboTrap® Revascularization Device is the investigational device | Device: EmboTrap® Revascularization Device<br> <br> * Other names: EmboTrap;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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