Evaluation of the Safety and Performance of Magneto Microcatheter

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: Magneto Microcatheter

• Registration Number: NCT04466033
• Lead Sponsor: Magneto Thrombectomy Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-05
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Study Start: 2020-11-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 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 blood pressure>110) refractory to pharmacological management
7. Pregnant or lactating female
8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score<6, mass effect and/or intracranial tumor
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magneto Microcatheter	Magneto Microcatheter	-

Primary Outcome Measures

Name	Time	Method
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	24 hours	Occurrence of device related Serious Adverse Events

Secondary Outcome Measures

Name	Time	Method
Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure	90 days	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	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)

Trial Locations

Locations (3)

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

Shaare Zedek; 🇮🇱 Jerusalem, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel