MASTER-II

Objective

The objective of the MASTER-II Trial is to evaluate the safety and efficacy of the MGuardTM Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) as compared with U.S. FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stent.).

Study design

Prospective, multi-center, randomized IDE trial. A total of 1114 subjects (557 in the MGuardTM Prime System group and 557 in the control group), at up to 70 sites worldwide. The primary efficacy endpoint is the rate of complete ST-segment resolution within 60-90 minutes of completion of the stent procedure, powered to demonstrate superiority of the MGuardTM Prime Stent compared to the control arm. The primary safety endpoint is a composite of all-cause death or recurrent target vessel myocardial infarction (TV re-MI) at 365 days post-procedure, powered to demonstrate non-inferiority of the MGuardTM Prime Stent compared to the control arm.