Back to resultsEvaluation of the Safety and Performance of Magneto Microcatheter
Primary Purpose
Ischemic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Magneto Microcatheter
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Clinical signs consistent with acute ischemic stroke
- Patient with Acute Ischemic Stroke within 24 hours from symptoms o
- Age 18-85 years old
- Consent process is completed per international and local regulations
Exclusion Criteria:
- Known use of cocaine or other vasoactive substance
- Known bleeding diathesis
- Any known hemorrhagic or coagulation deficiency.
- Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;
- PTT (Partial Thromboplastin Time)>2 at screening
- Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic blood pressure>110) refractory to pharmacological management
- Pregnant or lactating female
- CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor
- Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
Sites / Locations
- Shaare Zedek
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magneto Microcatheter
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
Occurrence of device related Serious Adverse Events
Secondary Outcome Measures
Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
Occurrence of device related Serious Adverse Events
Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)
Full Information
NCT ID
NCT04466033
First Posted
July 5, 2020
Last Updated
June 24, 2021
Sponsor
Magneto Thrombectomy Solutions
1. Study Identification
Unique Protocol Identification Number
NCT04466033
Brief Title
Evaluation of the Safety and Performance of Magneto Microcatheter
Official Title
Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
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 Microcatheter 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
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magneto Microcatheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Magneto Microcatheter
Intervention Description
All patients will be treated with Magneto Microcatheter
Primary Outcome Measure Information:
Title
Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
Description
Occurrence of device related Serious Adverse Events
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
Description
Occurrence of device related Serious Adverse Events
Time Frame
90 days
Title
Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
Description
Assessment of device performance in clot removal (TICI scale to evaluate revascularization) and ease of use (questionnaire that will be completed by the treating physician post procedure)
Time Frame
During Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical signs consistent with acute ischemic stroke
Patient with Acute Ischemic Stroke within 24 hours from symptoms o
Age 18-85 years old
Consent process is completed per international and local regulations
Exclusion Criteria:
Known use of cocaine or other vasoactive substance
Known bleeding diathesis
Any known hemorrhagic or coagulation deficiency.
Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;
PTT (Partial Thromboplastin Time)>2 at screening
Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic blood pressure>110) refractory to pharmacological management
Pregnant or lactating female
CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor
Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Sharon
Phone
0765300768
Email
shelly@magts.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Marzelik
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr.Amsalem
Organizational Affiliation
Shaare Zedek, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek
City
Jerusalem
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaakov Amsalem, Dr
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oleg Merzlyak, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Safety and Performance of Magneto Microcatheter
We'll reach out to this number within 24 hrs