MASTER-OCT
Research type
Research Study
Full title
OCT study of the MGuard Prime Embolic Protection Stent in Patients with Acute ST-segment Elevation Myocardial Infarction
IRAS ID
158574
Contact name
Miriam Ivenshitz
Contact email
Sponsor organisation
InspireMD Ltd
Duration of Study in the UK
1 years, 6 months, 10 days
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. A heart attack is treated by opening up the blockage and placing a stent in a procedure called percutaneous coronary intervention (PCI).
The randomised trial compares the safety MGuard Prime Embolic protection stent to other commercially available stents (bare metal stent (BMS) or drug eluting stents (DES).
The study stent is a bare metal stent (BMS) wrapped in a fine fiber mesh. The study will assess if the fiber mesh prevents blood clots and debris from entering the blood vessel and blocking the free are where the blood in the artery could flow
A total of 234 patients will be recruited from up to 15 different hospitals in Germany, Poland and the UK.
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. In addition they will have a special type of imaging done in the artery which can measure the blood flow area.
Patients will be followed in the study for 30 days.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1690
Date of REC Opinion
6 Nov 2014
REC opinion
Further Information Favourable Opinion