Clinical trial NCT06495671: Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Official title: Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Stroke
Keywords: thrombolysis
thrombolytic
endovascular thrombectomy
nanoparticle
magnetically enhanced diffusion
digital subtraction angiography
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Monash University
name: Euphrates Vascular, Inc.
First posted: 2024-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bayesian optimal phase 2 trial
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Proportion of participants with substantial reperfusion at final angiography (15 +/- 5min after final nanoparticle injection) without symptomatic intracranial hemorrhage on CT/MRI at 24h
timeFrame: 24 hours +/- 6 hours
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: 15 minutes +/- 5 minutes after completion of the final nanoparticle injection
measure: Symptomatic intracranial hemorrhage
timeFrame: 24 hours +/- 6 hours
measure: Procedural arterial perforation
timeFrame: 24 hours +/- 6 hours
measure: Death due to any cause
timeFrame: 90 days +/- 7 days
measure: modified Rankin Scale (mRS) at 3 months
timeFrame: 90 days +/- 7 days
measure: modified Rankin Scale (mRS) 0-1 or no change from baseline at 3 months
timeFrame: 90 days +/- 7 days
measure: modified Rankin Scale (mRS) 0-2 or no change from baseline at 3 months
timeFrame: 90 days +/- 7 days
measure: Early neurological improvement
timeFrame: 3 days +/- 1 day or discharge if earlier
measure: Reperfusion at 24 hours
timeFrame: 24 hours +/- 6 hours
measure: Recanalization at 24 hours
timeFrame: 24 hours +/- 6 hours
Locations:
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Bruce CV Campbell, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Ronil V Chandra, MBBS FRANZCR
role: PRINCIPAL_INVESTIGATOR
References: