Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
NCT Number: NCT06495671
Acronym: AusNanoMED
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ischemic Stroke|Stroke
Interventions: DEVICE: Magnetically enhanced diffusion
Sponsor: University of Melbourne
Collaborators: Monash University|Euphrates Vascular, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-03-31
Locations: John Hunter Hospital, Newcastle, New South Wales, 2305, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|The Alfred Hospital, Melbourne, Victoria, 3004, Australia|The Austin Hospital, Melbourne, Victoria, 3084, Australia|Monash Medical Centre, Melbourne, Victoria, 3168, Australia|The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia

Summary:
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.

Primary Outcome Measures: 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, 24 hours +/- 6 hours
Other Outcome Measures: 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, 15 minutes +/- 5 minutes after completion of the final nanoparticle injection|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, 24 hours +/- 6 hours|Procedural arterial perforation, Procedural arterial perforation that results in visible extravasation of contrast into the subarachnoid space, 24 hours +/- 6 hours|Death due to any cause, Death due to any cause within 90 days, 90 days +/- 7 days|modified Rankin Scale (mRS) at 3 months, 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)., 90 days +/- 7 days|modified Rankin Scale (mRS) 0-1 or no change from baseline at 3 months, 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)., 90 days +/- 7 days|modified Rankin Scale (mRS) 0-2 or no change from baseline at 3 months, 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)., 90 days +/- 7 days|Early neurological improvement, 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)., 3 days +/- 1 day or discharge if earlier|Reperfusion at 24 hours, Resolution of perfusion lesion (\<5mL region of brain with hypoperfusion defined as Tmax delay \>6 sec) at 24 hours, 24 hours +/- 6 hours|Recanalization at 24 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)., 24 hours +/- 6 hours