Ischemic Stroke
Conditions
Brief summary
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.
Interventions
DEVICEMagneto Wire
Patients will be treated with Magneto Wire
Sponsors
Magneto Thrombectomy Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 24 (±8) hours post procedure | Occurrence of Device-related Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 90 (±10) days | Occurrence of Device-related Serious Adverse Events (SAEs) |
| Revascularization | immediate | Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b) |
| Distal Embolism | immediate | Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram |
| National Institutes of Health Stroke Scale (NIHSS) | 24 (±8) hours post procedure | 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. |
| Modified Rankin Scale | 90 (±10) days | 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) |
Countries
Israel
Outcome results
None listed