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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01519076




Registration number
NCT01519076
Ethics application status
Date submitted
18/01/2012
Date registered
26/01/2012
Date last updated
10/12/2014

Titles & IDs
Public title
A Safety Evaluation of the Use of Magnetic-guided Iron Particles
Scientific 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)
Secondary ID [1] 0 0
PTI_CS001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)

Treatment: Devices: 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).

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
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".
Timepoint [1] 0 0
24 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Hunter New England - New Lambton
Recruitment hospital [2] 0 0
Eastern Health Services Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
- New Lambton
Recruitment postcode(s) [2] 0 0
- Box Hill

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pulse Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01519076
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Bladin, MD
Address 0 0
Eastern Health Services Box Hill Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01519076