Evaluation of the Safety and Performance of Magneto Microcatheter

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 Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.

Official Title
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Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Magneto Microcatheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical signs consistent with acute ischemic stroke Patient with Acute Ischemic Stroke within 24 hours from symptoms o Age 18-85 years old Consent process is completed per international and local regulations Exclusion Criteria: Known use of cocaine or other vasoactive substance Known bleeding diathesis Any known hemorrhagic or coagulation deficiency. Current use of oral anticoagulants with International Normalized Ratio (INR) > 3; PTT (Partial Thromboplastin Time)>2 at screening Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic blood pressure>110) refractory to pharmacological management Pregnant or lactating female CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.

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 Microcatheter<br> | Device: Magneto Microcatheter<br>* All patients will be treated with Magneto Microcatheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure | Occurrence of device related Serious Adverse Events | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure | Occurrence of device related Serious Adverse Events | 90 days | 
| Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use | Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure) | During Procedure |