Safety and Performance Evaluation of the Magneto Wire

Magneto Thrombectomy Solutions

Status: Terminated

Conditions: Ischemic Stroke

Treatments: Device: Magneto Wire

Study type: Interventional

Funder types: Industry

Identifiers

NCT03890380

CLP-01

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Magneto Wire

Experimental group

Description:

Patients treated with Magneto Wire

Treatment:

Device: Magneto Wire