Ischemic Stroke
Conditions
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
Brief 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. 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.
Interventions
Sponsors
Neuravi Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Revascularisation Following the Use of the Neuravi Device. | Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Post Procedure | 7 and 90(±14) days post procedure | All procedure related mortality (i.e. directly traceable to a procedure related SAE). |
| Serious Adverse Device Related Effects (SADE) | 24(-8/+12) hours Post Procedure | 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. |
| Symptomatic ICH | 24(-8/+12) hours Post Procedure | 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. |
| Time to Revascularization | Day 1 | Defined as time from groin puncture to visualization of final angiographic result. |
| Rate of New Territory Embolization | 24(-8/+12) hours Post Procedure | 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. |
| Evidence of Infarction | 24(-8/+12) hours Post Procedure | Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab. |
| Clinical Outcome at 90 Days | 90(±14) days Post Procedure | 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. |
Countries
Denmark, Germany, Ireland, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EmboTrap® Revascularization Device The EmboTrap® Revascularization Device is the investigational device
EmboTrap® Revascularization Device | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | EmboTrap® Revascularization Device | — |
|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 14 | — |
| Body Mass Index (BMI) | 27 kg/m^2 STANDARD_DEVIATION 4 | — |
| National Institutes of Health Stroke Scale (NIHSS) Score | 15 units on a scale STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 6 participants | — |
| Region of Enrollment Germany | 6 participants | — |
| Region of Enrollment Ireland | 4 participants | — |
| Region of Enrollment Spain | 10 participants | — |
| Region of Enrollment Sweden | 14 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 25 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 40 |
| serious Total, serious adverse events | 9 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmboTrap® Revascularization Device | Proportion of Revascularisation Following the Use of the Neuravi Device. | 28 Participants |
Secondary
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
Population: Data was not collected for all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmboTrap® Revascularization Device | Clinical Outcome at 90 Days | 20 Participants |
Secondary
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
Population: Data were not collected
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EmboTrap® Revascularization Device | Mortality Post Procedure | Procedure-related Mortality at Day 7 | 0 Participants |
| EmboTrap® Revascularization Device | Mortality Post Procedure | All cause Mortality at Day 90 | 4 Participants |
Secondary
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
Population: Data were not collected
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmboTrap® Revascularization Device | Serious Adverse Device Related Effects (SADE) | 0 Participants |
Secondary
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.
Time frame: 24(-8/+12) hours Post Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EmboTrap® Revascularization Device | Symptomatic ICH | 0 Participants |
Secondary
Time to Revascularization
Defined as time from groin puncture to visualization of final angiographic result.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EmboTrap® Revascularization Device | Time to Revascularization | 76 minutes | Standard Deviation 50 |