Back to resultsA Safety Evaluation of the Use of Magnetic-guided Iron Particles
Primary Purpose
Ischemic Stroke
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke
Eligibility 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.
Sites / Locations
- Hunter New England
- Eastern Health Services Box Hill Hospital
Outcomes
Primary Outcome Measures
Safety: incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with tPA alone.
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
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01519076
Brief Title
A Safety Evaluation of the Use of Magnetic-guided Iron Particles
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Request
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulse Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Safety: incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with tPA alone.
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Brain Recanalization and perfusion
Description
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".
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bladin, MD
Organizational Affiliation
Eastern Health Services Box Hill Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter New England
City
New Lambton
State/Province
New South Wales
Country
Australia
Facility Name
Eastern Health Services Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
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A Safety Evaluation of the Use of Magnetic-guided Iron Particles
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