Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

NCT06495671 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MBC2402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

Ischemic Stroke; Stroke

Keywords

thrombolysis; thrombolytic; endovascular thrombectomy; nanoparticle; magnetically enhanced diffusion; digital subtraction angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  15 minutes +/- 5 minutes after completion of the final nanoparticle injection

• Symptomatic intracranial hemorrhage

  24 hours +/- 6 hours

• Procedural arterial perforation

  24 hours +/- 6 hours

Study Arms (1)

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.

Device: Magnetically enhanced diffusion

Interventions

Magnetically enhanced diffusion DEVICE

Iron nanoparticle (intra-arterial) + External magnet workstation

Also known as: PULSE Nanomed System

Magnetically enhanced diffusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead
• Monash University: collaborator
• Euphrates Vascular, Inc.: collaborator

Study Sites (7)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bruce CV Campbell, MBBS FRACP

  University of Melbourne

  PRINCIPAL INVESTIGATOR

• Ronil V Chandra, MBBS FRANZCR

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Campbell, MBBS FRACP

CONTACT

61393427000; bruce.campbell@mh.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Primary outcome assessed by blinded imaging core laboratory. Day 90 modified Rankin scale assessed by central blinded clinician.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Bayesian optimal phase 2 trial

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)