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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EmboTrap® Revascularization Device | The EmboTrap® Revascularization Device is the investigational device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmboTrap® Revascularization Device | Device |
|
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| 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 |
| 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). |
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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:
Exclusion Criteria:
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Ischemic stroke patients
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Tommy Andersson | Karolinska Institutet | Principal Investigator |
| Prof. Dr. Heinrich Mattle | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Universitätsklinikum Kiel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30563388 | Derived | 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. |
| Label | URL |
|---|---|
| Company website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | EmboTrap® Revascularization Device | The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EmboTrap® Revascularization Device | The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EmboTrap® Revascularization Device | The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mairsil Claffey | Neuravi Limited | 0035391394123 | mclaffey@neuravi.com |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001927 | Brain Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D007511 | Ischemia |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
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| 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 |
| Kiel |
| Germany |
| Beaumont Hospital | Dublin | Ireland |
| Hospital Clinico de Barcelona | Barcelona | Spain |
| Karolinska Institutet | Solna | 17176 | Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| National Institutes of Health Stroke Scale (NIHSS) Score | 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. | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time to Revascularization | Defined as time from groin puncture to visualization of final angiographic result. | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Mortality Post Procedure | All procedure related mortality (i.e. directly traceable to a procedure related SAE). | Posted | Count of Participants | Participants | 7 and 90(±14) days post procedure |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24(-8/+12) hours Post Procedure |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24(-8/+12) hours Post Procedure |
|
|
|
| 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. | Data was not collected for all participants. | Posted | Count of Participants | Participants | 90(±14) days Post Procedure |
|
|
|
| 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. | Data were not collected | Posted | 24(-8/+12) hours Post Procedure |
|
|
| Secondary | Evidence of Infarction | Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab. | Data were not collected | Posted | 24(-8/+12) hours Post Procedure |
|
|
| 9 |
| 40 |
| 24 |
| 40 |
| Stroke in evolution | Nervous system disorders |
|
| Embolism | Nervous system disorders |
|
| Neurological Deterioration | Nervous system disorders |
|
| Occlusion | Nervous system disorders |
|
| Pseudoaneurysm | Vascular disorders |
|
| Vessel perforation | Vascular disorders |
|
| Bradycardia | Cardiac disorders |
|
| Other Cardiac disorders | Cardiac disorders |
|
| Pneumonia | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Blood potassium decreased | Investigations |
|
| Embolism | Nervous system disorders |
|
| Haemorrhagic transformation stroke | Nervous system disorders |
|
| Other Respiratory disorders | Respiratory, thoracic and mediastinal disorders |
|
| Hypertension | Vascular disorders |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |