3743/0001_Pulse_MEDIS-INT16-002
Research type
Research Study
Full title
A PROSPECTIVE INTERNATIONAL MULTICENTRE RANDOMISED CONTROLLED SINGLE BLIND CLINICAL INVESTIGATION OF MAGNETICALLY ENHANCED DIFFUSION FOR ACUTE ISCHAEMIC STROKE (MEDIS-INTERNATIONAL)
IRAS ID
213579
Contact name
Keith Muir
Contact email
Sponsor organisation
Pulse Therapeutics, Inc.
Clinicaltrials.gov Identifier
CIV-GB-16-09-016827, Eudamend number
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Most strokes result from a blood clot blocking an artery in the brain, starving tissue of oxygen and nutrients (“ischemic stroke”) and resulting in permanent damage. Prompt treatment with clot-dissolving drugs (“thrombolysis”) improves the chances of recovering, but this treatment has only a limited effect when a major blood vessel is blocked by a large clot. These major blood vessel blockages cause extensive brain damage and commonly result in death or permanent disability.
Recent studies of devices that remove clots directly after being fed through the arteries to the brain have confirmed that opening the blocked vessel significantly improves the chances of recovery. Unfortunately, this procedure requires highly specialised facilities and is not available to most patients. Alternative approaches to restoring blood flow are therefore needed.
This study will test a device, the MED system, designed to improve the chances of opening a blocked artery in these severely affected patients. The system uses two components: an intravenous injection of iron-based particles (“micro-beads”) that circulate in the bloodstream; and a magnetic device placed next to the patient’s head to concentrate the micro-beads at the site of the blockage, and cause them to rotate. This rotation improves both the speed and effectiveness of clot breakdown by circulating the clot-dissolving drug more effectively at the site of the blockage.The study will involve patients with stroke caused by a large vessel occlusion who are being treated with the clot-dissolving drug tPA, randomly allocating participants to the MED system injection or a placebo injection, and looking at the effect on opening the blocked blood vessel 30-90 minutes after treatment.
The study is a multi-centre, randomised, controlled trial that will enrol up to 120 patients at approximately 15 sites over 27 months.REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0566
Date of REC Opinion
21 Dec 2016
REC opinion
Further Information Favourable Opinion