Boston Scientific has started patient enrollment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of the company's OMEGA platinum chromium bare-metal coronary stent system in treating patients with a single coronary artery lesion. This prospective, single-arm trial will enroll 328 patients at 40 sites in the U.S. and Europe. The first patient was enrolled this week by Andrejs Erglis, M.D., OMEGA principal investigator, at Paul Stradins Clinical University Hospital in Riga, Latvia. The trial's coordinating principal investigators are John Wang, M.D., of Union Memorial Hospital in Baltimore, Maryland, and Christian Hamm, M.D., of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.
The primary endpoint of the OMEGA trial is nine-month target lesion failure (TLF), a composite measure that includes target lesion revascularization, myocardial infarction and cardiac death. TLF rates will be compared to a pre-specified performance goal based on historical clinical 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. Trial data will be used to support FDA approval.