NCT06495671Not yet recruiting
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)
Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT06495671
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Aug 2024 to the primary completion date, 31 Dec 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current participation in another investigational drug or device treatment study
Other illness
- Intracranial hemorrhage (ICH) identified by CT or MRI
- Pre-stroke mRS score of ≥ 3 (indicating functional dependence)
- 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.
- Any terminal illness such that patient would not be expected to survive more than 6 months
- 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.
Other
- Rapidly improving symptoms at the discretion of the investigator
- Frank hypodensity in \>1/3 of the affected arterial territory on non-contrast CT
- CT Perfusion ischemic core volume \> 100 ml
- Known aortic dissection
- Suspected septic embolization
- Contra indication to imaging with contrast agents
- Pregnant or lactating women
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| The Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Monash Medical Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| John Hunter Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.