Safety and Performance Evaluation of the Magneto Wire

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 Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Magneto Wire

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magneto Wire; Patients treated with Magneto Wire	Device: Magneto Wire; Patients will be treated with Magneto Wire

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	Occurrence of Device-related Serious Adverse Events (SAEs)	90 (±10) days
Revascularization	Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)	immediate
Distal Embolism	Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram	immediate
National Institutes of Health Stroke Scale (NIHSS)	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.	24 (±8) hours post procedure
Modified Rankin Scale	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)	90 (±10) days

Collaborators and Investigators

• Sponsor: Magneto Thrombectomy Solutions
• Investigators: Study Director: Shally Sharon, Magneto Thrombectomy Solutions

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): October 27, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CLP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No