Safety and Performance Evaluation of the Magneto Wire

NCT ID: NCT03890380

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2019-10-27

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magneto Wire

Patients treated with Magneto Wire

Group Type: EXPERIMENTAL

Magneto Wire

Intervention Type: DEVICE

Patients will be treated with Magneto Wire

Interventions

Magneto Wire

Patients will be treated with Magneto Wire

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magneto Thrombectomy Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shally Sharon

Role: STUDY_DIRECTOR

Magneto Thrombectomy Solutions

Locations

Rambam Health Care Campus

Haifa, , Israel

Countries

Israel

Other Identifiers

CLP-01

Identifier Type: -

Identifier Source: org_study_id