InspireMD, Inc. (OTC BB: NSPR) announced that the 313th patient has been enrolled in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial. The trial is scheduled to enroll 432 patients in total and the Company is on track to release preliminary top line results in the third quarter of 2012.
The MASTER Trial is a multinational randomized controlled trial designed to
evaluate the MGuard™ Coronary Stent compared with the standard of care for acute ST-elevation myocardial infarction (STEMI) patients. It seeks to enroll 432 patients in a two-arm, parallel design study. The objective is to evaluate the MGuard™ stent compared to commercially-approved bare metal stents (BMS) or drug eluting stents (DES) in achieving myocardial reperfusion in primary angioplasty for the treatment of STEMI patients. The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and important secondary endpoints such as TIMI (Thrombolysis In Myocardial Infarction) flow, MBG (Myocardial Blush Grade) and MACE (Major Adverse Cardiac Events) will be measured. Additional sub-studies include cardiac MRI whose enrollment is ongoing, as well as an invasive angiographic follow-up whose enrollment has ended. Dr. Gregg Stone, Director of Cardiovascular Research and Education, Columbia University in New York, is the study chairman.
The MASTER Trial is being conducted in 9 countries: Germany, Hungary, Israel, Poland, Czech Republic, France, Ireland, Brazil and South Africa. It is actively enrolling patients in 51 centers. The trial’s principal investigators are Prof. Alexandre Abizaid of the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, Prof. Dariusz Dudek from Jagiellonian University in Krakow, Poland, and Prof. Sigmund Silber of University of Munich, Germany. Detailed results from the trial are expected to be submitted for presentations at interventional cardiology meetings in the second half of the year.