Status:
NOT_YET_RECRUITING
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Monash University
Euphrates Vascular, Inc.
Conditions:
Ischemic Stroke
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06495671
Start Date
August 1 2024
End Date
March 31 2027
Last Update
July 11 2024
Active Locations (7)
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1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
The Alfred Hospital
Melbourne, Victoria, Australia, 3004