July 29, 2011 — InspireMD Inc., developer of the MGuard mesh protective stent system, announced that the first patient has been enrolled in the MASTER (MGuard for Acute ST Elevation Reperfusion) randomized trial. It is a multinational, randomized, controlled trial designed to demonstrate MGuard coronary stent's superiority over standard care for heart attack patients.
The patient was enrolled in the department of haemodynamics and angiocardiography, headed by Dr. Krystrof Zmudka, at the Krakow Specialist Hospital - John Paul II in Krakow, Poland.
The MASTER trial will enroll 432 patients in a two-arm parallel design. The objective is to demonstrate superiority of the MGuard stent over commercially approved bare-metal stents (BMS) or drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).
The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year. Other important secondary endpoints such as thrombosis in myocardial infarction (TIMI) flow, myocardial blush grade and major adverse cardiac events (MACE) rate will be measured.
Sub studies for cardiac MRI and invasive angiography are planned as well. Gregg Stone, M.D., director of cardiovascular research and education from Columbia University in New York, is the study chairman.
The randomized trial will be carried out in 50 centers throughout Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Poland and South Africa. The trial's principal investigators are Alexandre Abizaid, M.D.; Dariusz Dudek, M.D. and Prof. Sigmund Silber.
For more information: www.inspire-md.com