A Safety Evaluation of the Use of Magnetic-guided Iron Particles

Ischemic Stroke Clinical Trial

Official title: A Feasibility Study: A Safety Evaluation of the Use of Magnetic-guided Iron Particles Administered to Patients Suffering Acute Ischemic Stroke and Treated With Tissue Plasminogen Activator (tPA)

Status Terminated

Clinical Trial Summary

This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.

Clinical Trial Description

This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.

Subjects who meet the eligibility criteria will be treated with Magnetically Enhanced Diffusion (MED) concurrently with tPA infusion. Perfusion will be assessed using CTA/CTP at 2-4 hours upon completion of tPA infusion and using MRI at 24 hours upon completion of tPA infusion. Subjects are followed at 14 days, 30 days and 90 days post-treatment. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke

• NCT number: NCT01519076
• Study type: Interventional
• Source: Pulse Therapeutics
• Status: Terminated
• Phase: Phase 1
• Start date: June 2012
• Completion date: July 2014