Safety and Performance Evaluation of the Magneto Wire

Not Applicable

Terminated

• Conditions: Ischemic Stroke
• Interventions: Device: Magneto Wire

• Registration Number: NCT03890380
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Primary Completion: 2019-07-18
• Study Completion: 2019-10-27
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magneto Wire	Magneto Wire	Patients treated with Magneto Wire

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel