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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Pulse Therapeutics.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Pulse Therapeutics
ClinicalTrials.gov Identifier:
NCT01519076
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Device: Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by Pulse Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Brain Recanalization and perfusion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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".


Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
    The PTI MED System is a magnetic-controlled infusion system which uses external energy (magnetic energy) to drive an agent (tPA) to the desired target (blood clot).
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is between 18 and 80 years of age.
  • Subject has moderate to large (NIHSS ≥ 10 and ≤24) ischemic stroke
  • Subject has an intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery confirmed by CT or MR angiography.
  • Subject is eligible for initiation of intravenous tPA within three hours of stroke onset, where time of stroke onset is defined as the last time the patient was witnessed to be at baseline.

Exclusion Criteria:

  • Subject has known sensitivity to iron or PEG products.
  • Subject has recently (within 30 days) received iron replacement therapy.
  • Subject has known or suspect liver function abnormality.
  • Subject has known or suspect severe renal impairment.
  • Subject has a high-density lesion on baseline CT scan consistent with hemorrhage of any degree.
  • Subject has a significant mass on baseline CT consistent with midline shift.
  • Subject has a large (greater than one-third of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan.
  • Subject has evidence of intraparenchymal tumor on baseline CT scan.
  • Subject experiences a seizure at the onset of stroke.
  • Subject has known hemosiderosis or hemochromatosis.
  • Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI.
  • Subject has a history of stroke within the last three months.
  • Subject has a previous or existing intracranial hemorrhage, neoplasm, subarachnoid hemorrhage or arteriovenous malformation.
  • Subject has experienced any active or recent (within 30 days) hemorrhage.
  • Subject has systolic blood pressure > 185 mmHg or diastolic > 110 mmHg.
  • Subject has presumed septic embolus or suspicion of bacterial endocarditis.
  • Subject has presumed pericarditis including pericarditis after acute myocardial infarction.
  • Subject is suspected to have an aortic dissection.
  • Subject has recently (within 30 days) undergone surgery or biopsy of a parenchymal organ.
  • Subject has recently (within 30 days) experienced trauma with internal injuries or ulcerative wounds.
  • Subject has recently (within 90 days) experienced severe head trauma with loss of consciousness.
  • Subject has known hereditary or acquired hemorrhage diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 1.7 or institutionally equivalent prothrombin time.
  • Subject has a glucose level of < 50 mg/dl or >400 mg/dl, or a platelet count less than 100,000, or an Hct level less than 25.
  • Subject has taken dabigatran within the last 48 hours or any new anticoagulant which cannot be monitored by traditional.
  • Subject requires hemodialysis or peritoneal dialysis, or has a contraindication to angiogram.
  • Subject has prolonged partial thromboplastin time (PTT) (in the case where heparin or a direct thrombin inhibitor has been administered within 48 hours).
  • Subject has had a recent (within 7 days) lumbar puncture or arterial puncture at a non-compressible site.
  • Subject has a pre-existing neurological or psychiatric disease that would confound evaluations.
  • Subject is pregnant, nursing or intends to become pregnant during the trial period.
  • Subject is currently enrolled in other potentially confounding research.
  • Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519076

Locations
Australia, New South Wales
Hunter New England Not yet recruiting
New Lambton, New South Wales, Australia
Contact: Malcolm Evans       Malcolm.Evans@hnehealth.nsw.gov.au   
Principal Investigator: Mark Parsons, MD         
Australia, Victoria
Eastern Health Services Box Hill Hospital Not yet recruiting
Box Hill, Victoria, Australia
Contact: Zofia Ross       zofia.ross@monash.edu   
Principal Investigator: Chris Bladin, MD         
Sponsors and Collaborators
Pulse Therapeutics
Investigators
Principal Investigator: Christopher Bladin, MD Eastern Health Services Box Hill Hospital
  More Information

No publications provided

Responsible Party: Pulse Therapeutics
ClinicalTrials.gov Identifier: NCT01519076     History of Changes
Other Study ID Numbers: PTI_CS001
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Pulse Therapeutics:
stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 25, 2014