Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetically enhanced diffusion.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
Overview
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.
Interventions
- Device Magnetically enhanced diffusion
Iron nanoparticle (intra-arterial) + External magnet workstation
Primary outcome measures
- Proportion of participants with substantial reperfusion at final angiography (15 +/- 5min after final nanoparticle injection) without symptomatic intracranial hemorrhage on CT/MRI at 24h [Time frame: 24 hours +/- 6 hours]
Eligibility criteria
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)
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 7 centers
- John Hunter Hospital — Newcastle
- Royal North Shore Hospital — St Leonards
- Royal Adelaide Hospital — Adelaide
- The Alfred Hospital — Melbourne
- The Austin Hospital — Melbourne
- Monash Medical Centre — Melbourne
- The Royal Melbourne Hospital — Parkville
Identifiers
NCT: NCT06495671 · MBC2402