Trial of Omega Platinum Chromium Coronary Stent System now enrolling patients

Boston Scientific has started enrollment in the OMEGA clinical trial to evaluate the safety and effectiveness of its Omega Platinum Chromium Bare-Metal Coronary Stent System in treating patients with a single coronary artery lesion. The trial will enroll 328 patients at 40 sites in the U.S. and Europe. Rates of target lesion failure (TLF), a composite measure that includes target lesion revascularization, myocardial infarction and cardiac death, will be compared to a pre-specified performance goal based on studies of cobalt-chromium and stainless steel bare-metal stents. Patients will undergo clinical follow-up at 30 days, nine months and 12 months post-procedure and trial data will be used to support FDA approval. The trial's Coordinating Principal Investigators are John Wang of Union Memorial Hospital in Baltimore, Maryland, and Prof. Christian Hamm of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.