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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
Scientific title
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
Secondary ID [1] 0 0
MBC2402
Universal Trial Number (UTN)
Trial acronym
AusNanoMED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
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 - 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
24 hours +/- 6 hours

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
The Austin Hospital - Melbourne
Recruitment hospital [6] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3084 - Melbourne
Recruitment postcode(s) [6] 0 0
3168 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Euphrates Vascular, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06495671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce CV Campbell, MBBS FRACP
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bruce Campbell, MBBS FRACP
Address 0 0
Country 0 0
Phone 0 0
61393427000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06495671