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Safety and Performance Evaluation of the Magneto Wire

Primary Purpose

Ischemic Stroke

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Magneto Wire

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magneto Wire

Arm Description

Patients treated with Magneto Wire

Outcomes

Primary Outcome Measures

Safety Assessment

Occurrence of Device-related Serious Adverse Events (SAEs)

Secondary Outcome Measures

Safety Assessment

Occurrence of Device-related Serious Adverse Events (SAEs)

Revascularization

Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)

Distal Embolism

Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram

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.

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)

Full Information

NCT ID

NCT03890380

First Posted

March 25, 2019

Last Updated

July 1, 2020

Sponsor

Magneto Thrombectomy Solutions

1. Study Identification

Unique Protocol Identification Number

NCT03890380

Brief Title

Safety and Performance Evaluation of the Magneto Wire

Official Title

Safety and Performance Evaluation of the Magneto Wire

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision

Study Start Date

December 17, 2018 (Actual)

Primary Completion Date

July 18, 2019 (Actual)

Study Completion Date

October 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Magneto Thrombectomy Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magneto Wire

Arm Type

Experimental

Arm Description

Patients treated with Magneto Wire

Intervention Type

Device

Intervention Name(s)

Magneto Wire

Intervention Description

Patients will be treated with Magneto Wire

Primary Outcome Measure Information:

Title

Safety Assessment

Description

Occurrence of Device-related Serious Adverse Events (SAEs)

Time Frame

24 (±8) hours post procedure

Secondary Outcome Measure Information:

Title

Safety Assessment

Description

Occurrence of Device-related Serious Adverse Events (SAEs)

Time Frame

90 (±10) days

Title

Revascularization

Description

Revascularization in the immediate post procedure angiogram, using modified Thrombolysis in Cerebrovascular Infarction (mTIC≥2b)

Time Frame

immediate

Title

Distal Embolism

Description

Evidence of Infarction of a previously uninvolved vascular territory in the immediate post procedure angiogram

Time Frame

immediate

Title

National Institutes of Health Stroke Scale (NIHSS)

Description

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.

Time Frame

24 (±8) hours post procedure

Title

Modified Rankin Scale

Description

Time Frame

90 (±10) days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shally Sharon

Organizational Affiliation

Magneto Thrombectomy Solutions

Official's Role

Study Director

Facility Information:

Facility Name

Rambam Health Care Campus

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Performance Evaluation of the Magneto Wire

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