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NCT Number: NCT06495671

Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, Newcastle, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetically enhanced diffusion

Device

Iron nanoparticle (intra-arterial) + External magnet workstation

Other names: PULSE Nanomed System

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

    Time frame: 24 hours +/- 6 hours

    • 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

Other 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

    Time frame: 15 minutes +/- 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

  2. Symptomatic intracranial hemorrhage

    Time frame: 24 hours +/- 6 hours

    • 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

  3. Procedural arterial perforation

    Time frame: 24 hours +/- 6 hours

    Procedural arterial perforation that results in visible extravasation of contrast into the subarachnoid space

  4. Death due to any cause

    Time frame: 90 days +/- 7 days

    Death due to any cause within 90 days

  5. modified Rankin Scale (mRS) at 3 months

    Time frame: 90 days +/- 7 days

    Modified Rankin Scale ranges from 0 (no symptoms of stroke) to 6 (death), high scores indicate worse outcome. Outcome is descriptive and ordinal analysis compared to historical control (adjusted for baseline NIHSS and age).

  6. modified Rankin Scale (mRS) 0-1 or no change from baseline at 3 months

    Time frame: 90 days +/- 7 days

    Modified Rankin Scale ranges from 0 (no symptoms of stroke) to 6 (death), high scores indicate worse outcome. Outcome is descriptive and compared to historical control (adjusted for baseline NIHSS and age).

  7. modified Rankin Scale (mRS) 0-2 or no change from baseline at 3 months

    Time frame: 90 days +/- 7 days

    Modified Rankin Scale ranges from 0 (no symptoms of stroke) to 6 (death), high scores indicate worse outcome. Outcome is descriptive and compared to historical control (adjusted for baseline NIHSS and age).

  8. Early neurological improvement

    Time frame: 3 days +/- 1 day or discharge if earlier

    8 point reduction in National Institutes of Health Stroke Scale (NIHSS) score or reaching 0-1 at 3 days. NIHSS ranges from 0-42 with higher scores representing more severe stroke. Outcome is descriptive and compared to historical control (adjusted for baseline NIHSS and age).

  9. Reperfusion at 24 hours

    Time frame: 24 hours +/- 6 hours

    Resolution of perfusion lesion (<5mL region of brain with hypoperfusion defined as Tmax delay >6 sec) at 24 hours

  10. Recanalization at 24 hours

    Time frame: 24 hours +/- 6 hours

    Resolution of arterial occlusion at 24 hours assessed using the arterial occlusive lesion (AOL) scale 3. AOL ranges from 0 (no recanalization) to 3 (complete recanalization).

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce Campbell, MBBS FRACP

CONTACT

[email protected]

61393427000

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • Euphrates Vascular, Inc.
  • Monash University

Registry information

Official study title

Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)

Acronym: AusNanoMED

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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