Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495671
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-26
Brief Title:
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke AusNanoMED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AusNanoMED
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None