Safety and Performance Evaluation of the Magneto Wire

Study Overview
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Brief Summary
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A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.

Official Title
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Safety and Performance Evaluation of the Magneto Wire

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Magneto Wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke within defined timelines. Age 18-85 years old NIHSS ≥ 8 No significant pre-stroke functional disability (mRS ≤ 1) Exclusion Criteria: Life expectancy of less than 90 days Neurological signs that are rapidly improving prior to or at time of treatment NIHSS≥30 or state of coma Ongoing seizure Current use of cocaine or other vasoactive substance Known bleeding diathesis Known hemorrhagic or coagulation deficiency Evidence of active systemic infection Current use of oral anticoagulants INR > 3 Administration of heparin or Novel Oral Anticoagulants within 48 hours preceding the onset of stroke and have an abnormal aPTT at presentation Platelet count < 50,000/mm3 Glucose <50 mg/dL (2.8 mmol, 2.6mM) Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management Known hypersensitivity or allergy to radiographic contrast agents Pregnancy or lactating female Subject already enrolled in a clinical study involving experimental medication or device CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor. Angiographic evidence of carotid dissection, or high grade stenosis that will prevent access to the clot, or cerebral vasculitis, or intracranial stenosis Blood vessel with extreme tortuosity or other conditions preventing the access of the device. Angiographic evidence of carotid dissection, complete cervical carotid occlusions or vasculitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magneto Wire<br>Patients treated with Magneto Wire | Device: Magneto Wire<br>* Patients will be treated with Magneto Wire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Occurrence of Device-related Serious Adverse Events (SAEs) | 24 (±8) hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Occurrence of Device-related Serious Adverse Events (SAEs) | 90 (±10) days | 
| Revascularization | Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b) | immediate | 
| Distal Embolism | Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram | immediate | 
| National Institutes of Health Stroke Scale (NIHSS) | NIHSS scale is used to evaluate the severity of a stroke by assessing the stroke-related neurologic deficit. Scores range from 0-42, a higher score indicates a higher severity. | 24 (±8) hours post procedure | 
| Modified Rankin Scale | Modified Rankin scale is used to evaluate the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-6 (0-no symptoms, 6- death) | 90 (±10) days |