Safety and Performance Evaluation of the Magneto Wire

NCT03890380 | Terminated DMC

• 1 other identifier: CLP-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Wire in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  Occurrence of Device-related Serious Adverse Events (SAEs)

  24 (±8) hours post procedure

Secondary Outcomes (5)

• Safety Assessment

  90 (±10) days

• Revascularization

  immediate

• Distal Embolism

  immediate

• National Institutes of Health Stroke Scale (NIHSS)

  24 (±8) hours post procedure

• Modified Rankin Scale

  90 (±10) days

Study Arms (1)

Magneto Wire

EXPERIMENTAL

Patients treated with Magneto Wire

Device: Magneto Wire

Interventions

Magneto Wire DEVICE

Patients will be treated with Magneto Wire

Magneto Wire

Eligibility Criteria

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

You may qualify if:

• Acute ischemic stroke within defined timelines.
• Age 18-85 years old
• NIHSS ≥ 8
• No significant pre-stroke functional disability (mRS ≤ 1)

You may not qualify if:

• Life expectancy of less than 90 days
• Neurological signs that are rapidly improving prior to or at time of treatment
• NIHSS≥30 or state of coma
• Ongoing seizure
• Current use of cocaine or other vasoactive substance
• Known bleeding diathesis
• Known hemorrhagic or coagulation deficiency
• Evidence of active systemic infection
• Current use of oral anticoagulants INR \> 3
• Administration of heparin or Novel Oral Anticoagulants within 48 hours preceding the onset of stroke and have an abnormal aPTT at presentation
• Platelet count \< 50,000/mm3
• Glucose \<50 mg/dL (2.8 mmol, 2.6mM)
• Uncontrolled hypertension (SBP\>185 or DBP\>110) refractory to pharmacological management
• Known hypersensitivity or allergy to radiographic contrast agents
• Pregnancy or lactating female

Sponsors & Collaborators

• Magneto Thrombectomy Solutions: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 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

• Shally Sharon

  Magneto Thrombectomy Solutions

  STUDY DIRECTOR

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: March 25, 2019
• First Posted: March 26, 2019
• Study Start: December 17, 2018
• Primary Completion: July 18, 2019
• Study Completion: October 27, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)