Safety and Performance Evaluation of the Magneto Wire

Ischemic Stroke Clinical Trial

Official title:

Safety and Performance Evaluation of the Magneto Wire

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03890380
• Other study ID #: CLP-01
• Status: Terminated
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: October 27, 2019

Study information

• Verified date: July 2020
• Source: Magneto Thrombectomy Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 27, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• Magneto Wire
Patients will be treated with Magneto Wire

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Magneto Thrombectomy Solutions

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	Occurrence of Device-related Serious Adverse Events (SAEs)	24 (±8) hours post procedure
Secondary	Safety Assessment	Occurrence of Device-related Serious Adverse Events (SAEs)	90 (±10) days
Secondary	Revascularization	Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC=2b)	immediate
Secondary	Distal Embolism	Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram	immediate
Secondary	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
Secondary	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