MGuard™ Embolic Protection Stent: Study Enrollment Complete

In short

Back in February we reported the story of how the MGuard™ stent from Israeli company InspireMD Inc. was gaining the plaudits of investigators in Chile for achieving microvascular reperfusion rates superior to the comparator bare metal stent in a clinical study. The MGuard proprietary stent platform incorporates an ultra-fine mesh which is designed to prevent embolus formation. Now InspireMD has announced that it has completed enrollment in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial and is on track to release preliminary top line results in the third quarter of 2012.

Background

The MASTER Trial is a multinational randomised controlled trial designed to evaluate the MGuard™ and MGuard Prime Coronary Stents compared with the standard of care, bare metal stents (BMS) or drug eluting stents (DES), for acute ST-elevation myocardial infarction (STEMI) patients. It has enrolled 432 patients in a two-arm, parallel design study. 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. Sub-studies include infarct size measured by cardiac MRI, as well as restenosis by invasive angiographic follow-up at 13 months.

The MASTER Trial is being conducted in 50 centers in nine countries: Germany, Hungary, Israel, Poland, Czech Republic, France, Ireland, Brazil and South Africa. Dr. Gregg Stone, Director of Cardiovascular Research and Education, Columbia University in New York, is the study chairman. The trial’s principal investigators are Prof. Alexandre Abizaid of the Institute Dante Pazzanese de Cardiologia in Sao 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.

Company comments

Eli Bar, CTO and Vice President of Research and Development of InspireMD, commented: “This is an important milestone in the clinical development of MGuard™. The timely completion of enrollment has been achieved one month ahead of schedule. Completion of the MASTER trial is a key component of our plan to establish MGuard™ as the standard of care for Acute MI patients.”

Source: InspireMD Inc., PR Newswire