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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Magnetically enhanced diffusion
DeviceIron nanoparticle (intra-arterial) + External magnet workstation
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Magnetically enhanced diffusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with substantial reperfusion at final angiography (15 +/- 5min after final nanoparticle injection) without symptomatic intracranial hemorrhage on CT/MRI at 24h
* 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
Time frame
24 hours +/- 6 hoursOther outcomes
1
The proportion of participants with >90% reperfusion of the target occluded vessel territory at cerebral angiogram 15 (+/- 5) minutes after completion of the final nanoparticle injection
\- Near-complete reperfusion is defined as \>90% 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
Time frame
15 minutes +/- 5 minutes after completion of the final nanoparticle injection2
Symptomatic intracranial hemorrhage
\- 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
Time frame
24 hours +/- 6 hours3
Procedural arterial perforation
Procedural arterial perforation that results in visible extravasation of contrast into the subarachnoid space
Time frame
24 hours +/- 6 hours4
Death due to any cause
Death due to any cause within 90 days
Time frame
90 days +/- 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Melbourne
Lead sponsor
Monash University
Collaborator
Euphrates Vascular, Inc.
Collaborator
Source ClinicalTrials.gov
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