A Safety Evaluation of the Use of Magnetic-guided Iron Particles
|Ischemic Stroke||Device: Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Safety: incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with tPA alone. [ Time Frame: 90 days ]The primary measures of safety will be mortality at 3 months and symptomatic ICH within the first 24 hours post-treatment. All intracerebral hemorrhages (ICH) will be classified radiographically using the ECASS criteria. The proportion of subjects with Type II parenchymal intracerebral hematomas within the first 24 hours post-treatment and the incidence of any asymptomatic hemorrhage within the first 24 hours will also be compared.
- Brain Recanalization and perfusion [ Time Frame: 24 hours ]The degree of recanalization (partial and complete) and reperfusion will be assessed at 2-4 hours post-treatment using CT angiography, and at 24 +/- 6 hours post-treatment using MRI. TIMI Grade Flow of 2 or 3 will be considered "responsive to treatment".
|Study Start Date:||June 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Device: Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519076
|Australia, New South Wales|
|Hunter New England|
|New Lambton, New South Wales, Australia|
|Eastern Health Services Box Hill Hospital|
|Box Hill, Victoria, Australia|
|Principal Investigator:||Christopher Bladin, MD||Eastern Health Services Box Hill Hospital|