Evaluation of the Safety and Performance of Magneto Microcatheter

Magneto Thrombectomy Solutions4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke

Interventions

Magneto MicrocatheterDEVICE

All patients will be treated with Magneto Microcatheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical signs consistent with acute ischemic stroke 2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o 3. Age 18-85 years old 4. Consent process is completed per international and local regulations Exclusion Criteria: 1. Known use of cocaine or other vasoactive substance 2. Known bleeding diathesis 3. Any known hemorrhagic or coagulation deficiency. 4. Current use of oral anticoagulants with International Normalized Ratio (INR) \> 3; 5. PTT (Partial Thromboplastin Time)\>2 at screening 6. Uncontrolled hypertension (Systolic blood pressure\>185 or Diastolic blood pressure\>110) refractory to pharmacological management 7. Pregnant or lactating female 8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\<6, mass effect and/or intracranial tumor 9. 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.

Locations (3)

National Institute of Mental Health, Neurology and Neurosurgery)

Budapest, Hungary

Shaare Zedek

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 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)

Time frame: During Procedure

Data from ClinicalTrials.gov

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