Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Magnetically enhanced diffusion

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Melbourne

Lead sponsor

Monash University

Collaborator

Euphrates Vascular, Inc.

Collaborator