Evaluation of the Safety and Performance of Magneto Microcatheter

NCT04466033 | Completed DMC

• 1 other identifier: C14-CLN002
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 3

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.

Conditions

Ischemic Stroke

Outcome Measures

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

  Occurrence of device related Serious Adverse Events

  24 hours

Secondary Outcomes (2)

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

  90 days

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

  During Procedure

Study Arms (1)

Magneto Microcatheter

EXPERIMENTAL

Device: Magneto Microcatheter

Interventions

Magneto Microcatheter DEVICE

All patients will be treated with Magneto Microcatheter

Magneto Microcatheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Magneto Thrombectomy Solutions: lead

Study Sites (3)

National Institute of Mental Health, Neurology and Neurosurgery)

Budapest, Hungary

Location

Shaare Zedek

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Marzelik

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Dr.Amsalem

  Shaare Zedek, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 10, 2020
• Study Start: November 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); IL (2)