MASTER Trial Begins for InspireMD's MGuard Stent System

July 26, 2011—InspireMD, Inc. (Tel Aviv, Israel) announced commencement of the MASTER (MGuard for Acute ST-Elevation Reperfusion) trial with the initial patient enrollment at the Krakow Specialist Hospital–John Paul II in Krakow, Poland. The trial will be conducted at 50 centers in Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Poland, and South Africa. Gregg W. Stone, MD, is the trial's chairman. Alexandre Abizaid, MD, Dariusz Dudek, MD, and Prof. Sigmund Silber, MD, are the trial's principal investigators.

According to InspireMD, MASTER is a multinational, randomized controlled trial of the company's MGuard mesh protective coronary stent system. The trial will enroll 432 patients in a two-arm, parallel design, with the objective to demonstrate superiority of the MGuard stent over commercially approved bare-metal stents or drug-eluting stents in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction. The primary endpoint is complete ST-segment resolution. Clinical follow-up will continue for 1 year, and other important secondary endpoints such as TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and major adverse cardiac events rate will be measured. Substudies for cardiac magnetic resonance imaging and invasive angiography are also planned, the company stated.