MASTER II Trial (V6.0)
Research type
Research Study
Full title
MGuard™ Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction MGuard for Acute ST Elevation Reperfusion II - MASTER II Trial\n
IRAS ID
117432
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
InspireMD, Inc.
Clinicaltrials.gov Identifier
Research summary
A myocardial infarction or heart attack is caused by a blockage of one or more of the coronary arteries which supply blood to the heart itself. \n\nThis is an emergency situation and needs urgent treatment to open up the blocked artery. An angiogram is performed to take x ray images of the heart vessels to see where the problem is. To open the blocked artery, a metal mesh tube (stent) is placed in the blocked area in a procedure called percutaneous coronary intervention (PCI). \n\nThe randomised trial compares the safety and performance of the MGuard™ Prime Micronet Covered\nCoronary Stent System (MGuard™ Prime) against other commercially available stents (bare metal\nstent (BMS) or drug eluting stents (DES). This comparison will be done in emergency patients who are having a heart attack and require a PCI\n\nThe study stent is a bare metal stent (BMS) wrapped in a fibrefiber mesh. The study will assess if the fibre mesh system prevents or reduces damage to the smaller vessels of the heart, and reduces the size of the area affected by the heart attack (infarct size). \n\nA total of 1114 patients will be recruited from 70 different hospitals worldwide. Patients over 18 who are admitted to hospital with a heart attack will be eligible to take part in this study. They will be randomly allocated to receive either the study stent or another type of stent. Patients will undergo standard treatment for their heart attack. In addition they may be asked to have a Magnetic Resonance Imaging scan (MRI) after 5 days and another angiogram after one year. Patients will be followed in the study for approximately 13 months. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0263
Date of REC Opinion
3 Sep 2013
REC opinion
Further Information Favourable Opinion