Status:
COMPLETED
Evaluation of the Safety and Performance of Magneto Microcatheter
Lead Sponsor:
Magneto Thrombectomy Solutions
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04466033
Start Date
November 1 2020
End Date
July 1 2024
Last Update
May 7 2025
Active Locations (3)
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1
National Institute of Mental Health, Neurology and Neurosurgery)
Budapest, Hungary
2
Shaare Zedek
Jerusalem, Israel
3
Sheba Medical Center
Ramat Gan, Israel