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Safety and Performance Evaluation of the Magneto Wire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890380
Recruitment Status : Terminated (Sponsor's decision)
First Posted : March 26, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Magneto Thrombectomy Solutions

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Magneto Wire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the Magneto Wire
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : October 27, 2019

Arm Intervention/treatment
Experimental: Magneto Wire
Patients treated with Magneto Wire
Device: Magneto Wire
Patients will be treated with Magneto Wire




Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: 24 (±8) hours post procedure ]
    Occurrence of Device-related Serious Adverse Events (SAEs)


Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 90 (±10) days ]
    Occurrence of Device-related Serious Adverse Events (SAEs)

  2. Revascularization [ Time Frame: immediate ]
    Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)

  3. Distal Embolism [ Time Frame: immediate ]
    Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram

  4. 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.

  5. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890380


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Magneto Thrombectomy Solutions
Investigators
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Study Director: Shally Sharon Magneto Thrombectomy Solutions
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Responsible Party: Magneto Thrombectomy Solutions
ClinicalTrials.gov Identifier: NCT03890380    
Other Study ID Numbers: CLP-01
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No