Ischemic StrokeAusNanoMEDNCT06495671
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
A study testing Magnetically enhanced diffusion in people with Ischemic Stroke and Stroke, run by University of Melbourne at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Stroke
- What is being tested?
- Magnetically enhanced diffusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesAustralia
- Study dates
- 1 Aug 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Australia7 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Tim Kleinig, MBBS FRACP, 61 8 7074 0000, tim.kleinig@sa.gov.au
Tim Kleinig, MBBS FRACP
The Alfred Hospital
Melbourne, Victoria, 3004
Winston Chong, 61 3 9903 8655
Winston Chong
The Austin Hospital
Melbourne, Victoria, 3084
Hamed Asadi, +61 3 9496 4953
Hamed Asadi
Monash Medical Centre
Melbourne, Victoria, 3168
Ronil V Chandra, MBBS FRANZCR, +61 3 9594 3836
Ronil V Chandra, MBBS FRANZCR
John Hunter Hospital
Newcastle, New South Wales, 2305
Michelle Russell, RN, +61 2 4921 3481, michelle.russell@health.nsw.gov.au
Ferdi Miteff
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Bruce Campbell, MBBS FRACP, +61 3 9342 4424
Bruce Campbell
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Alice Ma, MBBS FRACP, 61 2 9926 7111
Alice Ma, MBBS FRACP
About this study
Official title: Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
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.
- Conditions
- Ischemic Stroke, Stroke
- Being tested
- Magnetically enhanced diffusion
- Keywords
- thrombolysis, thrombolytic, endovascular thrombectomy, nanoparticle, magnetically enhanced diffusion, digital subtraction angiography
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically enhanced diffusionDevice
Also called PULSE Nanomed System
Iron nanoparticle (intra-arterial) + External magnet workstation
| Study group | Role | What they receive |
|---|---|---|
| Magnetically enhanced diffusion | Experimental | Intra-arterial iron nanoparticles (4 x 1mg doses delivered every 3 minutes) delivered via microcatheter proximal to site of arterial occlusion(s) with external rotating magnet, total procedure 30min. Receives: Device: Magnetically enhanced diffusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours +/- 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bayesian optimal phase 2 trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Euphrates Vascular, Inc.
- Responsible party
- Sponsor
- Investigators
- Bruce CV Campbell, MBBS FRACP, Principal investigator, University of MelbourneRonil V Chandra, MBBS FRANZCR, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495671
- Sponsor's protocol ID
- MBC2402
- Acronym
- AusNanoMED
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
- ClinicalTrials.gov ID
- NCT06495671
- Acronym / sponsor ID
- AusNanoMED / MBC2402
- Conditions
- Ischemic Stroke, Stroke
- Keywords
- thrombolysis, thrombolytic, endovascular thrombectomy, nanoparticle, magnetically enhanced diffusion, digital subtraction angiography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Monash University, Euphrates Vascular, Inc.
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bayesian optimal phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Magnetically enhanced diffusion | Experimental | Device: Magnetically enhanced diffusionIntra-arterial iron nanoparticles (4 x 1mg doses delivered every 3 minutes) delivered via microcatheter proximal to site of arterial occlusion(s) with external rotating magnet, total procedure 30min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetically enhanced diffusionAlso: PULSE Nanomed SystemIron nanoparticle (intra-arterial) + External magnet workstation | Device | Magnetically enhanced diffusion |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce CV Campbell, MBBS FRACP principal investigator
University of Melbourne
Ronil V Chandra, MBBS FRANZCR principal investigator
Monash University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetically enhanced diffusion in people with Ischemic Stroke and Stroke, run by University of Melbourne at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Campbell, MBBS FRACP (61393427000, bruce.campbell@mh.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 hours +/- 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.