Safety and Performance Evaluation of the Magneto Wire

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 18, 2019

Interventions

  • Device: Magneto Wire
    • Patients will be treated with Magneto Wire

Arms, Groups and Cohorts

  • Experimental: Magneto Wire
    • Patients treated with Magneto Wire

Clinical Trial Outcome Measures

Primary Measures

  • Safety Assessment
    • Time Frame: 24 (±8) hours post procedure
    • Occurrence of Device-related Serious Adverse Events (SAEs)

Secondary Measures

  • Safety Assessment
    • Time Frame: 90 (±10) days
    • Occurrence of Device-related Serious Adverse Events (SAEs)
  • Revascularization
    • Time Frame: immediate
    • Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)
  • Distal Embolism
    • Time Frame: immediate
    • Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram
  • National Institutes of Health Stroke Scale (NIHSS)
    • Time Frame: 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
    • Time Frame: 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Magneto Thrombectomy Solutions
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shally Sharon, Study Director, Magneto Thrombectomy Solutions

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.