Evaluation of the Safety and Performance of Magneto Microcatheter

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466033
• Other study ID #: C14-CLN002
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Magneto Thrombectomy Solutions
• Contact: Shelly Sharon
• Phone: 0765300768
• Email: shelly[@]magts.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• Magneto Microcatheter
All patients will be treated with Magneto Microcatheter

Locations

Country	Name	City	State
Hungary	National Institute of Mental Health, Neurology and Neurosurgery)	Budapest
Israel	Shaare Zedek	Jerusalem
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Magneto Thrombectomy Solutions

Countries where clinical trial is conducted

Hungary,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure	Occurrence of device related Serious Adverse Events	90 days
Secondary	Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use	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)	During Procedure