Evaluation of the Safety and Performance of Magneto Microcatheter

Last updated: May 5, 2025
Sponsor: Magneto Thrombectomy Solutions
Overall Status: Completed

Phase

N/A

Condition

Occlusions

Cerebral Ischemia

Thrombosis

Treatment

Magneto Microcatheter

Clinical Study ID

NCT04466033
C14-CLN002
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical signs consistent with acute ischemic stroke

  2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o

  3. Age 18-85 years old

  4. Consent process is completed per international and local regulations

Exclusion

Exclusion Criteria:

  1. Known use of cocaine or other vasoactive substance

  2. Known bleeding diathesis

  3. Any known hemorrhagic or coagulation deficiency.

  4. Current use of oral anticoagulants with International Normalized Ratio (INR) > 3;

  5. PTT (Partial Thromboplastin Time)>2 at screening

  6. Uncontrolled hypertension (Systolic blood pressure>185 or Diastolic bloodpressure>110) refractory to pharmacological management

  7. Pregnant or lactating female

  8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, masseffect and/or intracranial tumor

  9. Angiographic evidence of either carotid dissection or vasculitis at the target siteor any condition that may limit device access to the target site (i.e high gradestenosis) per the treating physician's discretion.

Study Design

Total Participants: 4
Treatment Group(s): 1
Primary Treatment: Magneto Microcatheter
Phase:
Study Start date:
November 01, 2020
Estimated Completion Date:
July 01, 2024

Connect with a study center

  • National Institute of Mental Health, Neurology and Neurosurgery)

    Budapest,
    Hungary

    Site Not Available

  • Shaare Zedek

    Jerusalem,
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Site Not Available

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