Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

Launched by UNIVERSITY OF MELBOURNE · Jul 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients who have had an ischemic stroke, which occurs when a blood vessel in the brain gets blocked and prevents blood flow. The trial will test the use of tiny iron particles, injected directly into the artery in the brain, combined with an external magnet that helps pull these particles towards the clot. The goal is to restore blood flow by bringing fresh blood and clot-dissolving substances to the area of the blockage, potentially helping to reduce disability caused by the stroke.

To participate in this trial, patients need to be at least 18 years old and have experienced an ischemic stroke within the last 24 hours. They must also have a specific type of blockage visible on imaging tests. The trial is not currently recruiting, but once it begins, participants can expect to receive the injection through a small tube placed in their arm or leg, guided by X-ray. The entire procedure will take about 30 minutes, and the main focus will be on whether the treatment successfully opens the blocked artery without causing bleeding in the brain.

Gender

ALL

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.