Ischemic StrokePhase 1NCT01519076
A Safety Evaluation of the Use of Magnetic-guided Iron Particles
A Phase 1 study testing Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED) in people with Ischemic Stroke, run by Pulse Therapeutics at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 7 participants
- Where
- 2 sitesAustralia
- Study dates
- Jun 2012to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Eastern Health Services Box Hill Hospital
Box Hill, Victoria
Hunter New England
New Lambton, New South Wales
About this study
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)
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)
- Keywords
- stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)Device
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (1)
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".
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completionJul 2014
Why it stopped: Sponsor Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Bladin, MD, Principal investigator, Eastern Health Services Box Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519076
- Sponsor's protocol ID
- PTI_CS001
- Status last verified
- Dec 2014
- First submitted
- 18 Jan 2012
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01519076
- Acronym / sponsor ID
- PTI_CS001
- Conditions
- Ischemic Stroke
- Keywords
- stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Request
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pulse TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | – |
Primary outcome
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.
1 secondary outcome
Brain Recanalization and perfusion
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Sponsor Request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bladin, MD principal investigator
Eastern Health Services Box Hill Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED) in people with Ischemic Stroke, run by Pulse Therapeutics at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.