Evaluation of the Safety and Performance of Magneto Microcatheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Magneto Microcatheter

Group Type EXPERIMENTAL

Magneto Microcatheter

Intervention Type DEVICE

All patients will be treated with Magneto Microcatheter

Interventions

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Magneto Microcatheter

All patients will be treated with Magneto Microcatheter

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No