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OpenTrials
Completed

NCT Number: NCT04466033

Evaluation of the Safety and Performance of Magneto Microcatheter

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Mental Health, Neurology and Neurosurgery), Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magneto Microcatheter

Device

All patients will be treated with Magneto Microcatheter

Primary outcomes

  1. 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

    Time frame: 24 hours

    Occurrence of device related Serious Adverse Events

Secondary outcomes

  1. Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure

    Time frame: 90 days

    Occurrence of device related Serious Adverse Events

  2. Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use

    Time frame: During Procedure

    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)

Sponsors and collaborators

Lead sponsor

Magneto Thrombectomy Solutions

Industry

Registry information

Official study title

Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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