Tests magnetic nanoparticles to help open blocked brain arteries in stroke
Tests magnetic iron nanoparticles with an external magnet in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Key facts
- Where
- Adelaide, Melbourne, Newcastle, Parkville, and St Leonards, AustraliaSee the 7 sites
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaNo longer taking part
- Monash Medical CentreMelbourne, AustraliaNo longer taking part
- The Alfred HospitalMelbourne, AustraliaNo longer taking part
- The Austin HospitalMelbourne, AustraliaNo longer taking part
- John Hunter HospitalNewcastle, AustraliaNo longer taking part
- The Royal Melbourne HospitalParkville, AustraliaNo longer taking part
- Royal North Shore HospitalSt Leonards, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Melbourne
- Trial code
- NCT06495671
- Record updated
- 11 July 2024
- Original description
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.Read full original descriptionShow less
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
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.
Inclusion: 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: Current participation in another investigational drug or device treatment study; Intracranial hemorrhage (ICH) identified by CT or MRI; Pre-stroke mRS score of ≥ 3 (indicating functional dependence); 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; Any terminal illness such that patient would not be expected to survive more than 6 months; 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; Rapidly improving symptoms at the discretion of the investigator; Frank hypodensity in >1/3 of the affected arterial territory on non-contrast CT; CT Perfusion ischemic core volume > 100 ml; Known aortic dissection; Suspected septic embolization; Contra indication to imaging with contrast agents; Pregnant or lactating women.