Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06495671
Registration number
NCT06495671
Ethics application status
Date submitted
26/06/2024
Date registered
11/07/2024
Date last updated
11/07/2024
Titles & IDs
Public title
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Query!
Scientific title
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
Query!
Secondary ID [1]
0
0
MBC2402
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AusNanoMED
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
0
0
Query!
Stroke
0
0
Query!
Condition category
Condition code
Stroke
0
0
0
0
Query!
Haemorrhagic
Query!
Stroke
0
0
0
0
Query!
Ischaemic
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - Magnetically enhanced diffusion
Experimental: Magnetically enhanced diffusion - Intra-arterial iron nanoparticles (4 x 1mg doses delivered every 3 minutes) delivered via microcatheter proximal to site of arterial occlusion(s) with external rotating magnet, total procedure 30min.
Treatment: Devices: Magnetically enhanced diffusion
Iron nanoparticle (intra-arterial) + External magnet workstation
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of participants with substantial reperfusion at final angiography (15 +/- 5min after final nanoparticle injection) without symptomatic intracranial hemorrhage on CT/MRI at 24h
Query!
Assessment method [1]
0
0
* Substantial reperfusion is defined as \>50% reperfusion of the target occluded vessel territory at cerebral angiogram 15 (+/- 5) minutes after completion of the final nanoparticle injection. Target occluded vessel territory is defined based on the angiogram immediately prior to nanoparticle injection, as adjudicated by the core laboratory. * Symptomatic intracranial hemorrhage is defined according to the Heidelberg Classification as new intracranial hemorrhage detected by brain imaging within 24h associated with any of the items below in the absence of an alternative explanation for clinical deterioration: * =4 point increase in NIHSS at the time of diagnosis compared to the most recent NIHSS prior to worsening * =2 point increase in one NIHSS category * Leading to intubation/hemicraniectomy/external ventricular drain placement or other major medical/surgical intervention
Query!
Timepoint [1]
0
0
24 hours +/- 6 hours
Query!
Eligibility
Key inclusion criteria
* Patients presenting with ischemic stroke within 24 hours of the time they were last known to be well
* Patient's age is =18 years
* Legal requirements for consent as per local legislative requirements are satisfied.
* Distal medium vessel intracranial arterial occlusion visible on CT-angiography, MR-angiography or catheter digital subtraction angiography (DSA) in the middle cerebral, anterior or posterior cerebral artery. The occlusion may be primary or secondary (ie following initial mechanical thrombectomy of a large vessel occlusion)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Intracranial hemorrhage (ICH) identified by CT or MRI
* Rapidly improving symptoms at the discretion of the investigator
* Pre-stroke mRS score of = 3 (indicating functional dependence)
* Frank hypodensity in >1/3 of the affected arterial territory on non-contrast CT
* CT Perfusion ischemic core volume > 100 ml
* Known automated implantable cardiac defibrillator, pacemaker, cerebral aneurysm clip, cochlear implant, cranial neurostimulator or other device implant that is incompatible with the external magnetic field
* Known allergy or sensitivity to iron
* Known hemochromatosis, or known liver disease such as cirrhosis.
* Known aortic dissection
* Suspected septic embolization
* Contra indication to imaging with contrast agents
* Pregnant or lactating women
* Any terminal illness such that patient would not be expected to survive more than 6 months
* Current participation in another investigational drug or device treatment study
* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Not applicable
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/08/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2027
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
John Hunter Hospital - Newcastle
Query!
Recruitment hospital [2]
0
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [3]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [4]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [5]
0
0
The Austin Hospital - Melbourne
Query!
Recruitment hospital [6]
0
0
Monash Medical Centre - Melbourne
Query!
Recruitment hospital [7]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2305 - Newcastle
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3084 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
3168 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Melbourne
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Monash University
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
Euphrates Vascular, Inc.
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Rapidly restoring blood flow to the brain in patients with stroke caused by a blocked blood vessel in the brain is the key to reducing disability. Current treatments often leave small blocked arteries that cannot be safely opened with mechanical clot removal devices. Furthermore, stagnant flow limits access of clot-dissolving medication to the clot. This trial tests iron nanoparticles (similar to iron infused to replace low body stores but injected directly into the brain artery upstream of the blockage) combined with an external rotating magnet that draws the nanoparticles towards the clot, overcoming stagnant blood flow. The aim is to bring fresh blood which contains naturally-occurring clot-dissolving substances, and any clot-dissolving medication that may be circulating, to the surface of the clot with the aim of restoring blood flow to the brain. The trial will recruit up to 30 patients. All will receive injection of nanoparticles via an angiogram (small tube inserted into a leg or arm artery and fed up into the brain artery under Xray control). The procedure takes 30min and the degree of success in opening the artery at the end of procedure is the primary outcome, combined with an absence of symptomatic brain bleeding at 24h.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06495671
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bruce CV Campbell, MBBS FRACP
Query!
Address
0
0
University of Melbourne
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Bruce Campbell, MBBS FRACP
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
61393427000
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06495671
Download to PDF