Boston Scientific has initiated enrolling patients for its Omega Platinum Chromium Bare-Metal Coronary Stent System's clinical trial to treat patients with a single coronary artery lesion.
The single-arm, prospective trial enrolling 328 patients at 40 sites in the US and Europe is designed to assess the safety and effectiveness of the Omega Stent System.
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.
The Omega Stent System is part of Boston Scientific’s Platinum Chromium (PtCr) Stent series, and features the PtCr alloy and a stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil.
Boston other stents include the ION Paclitaxel-Eluting Stent System and the PROMUS Element Everolimus-Eluting Stent System.
TLF rates will be compared to a pre-specified performance goal based on 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.
The company said that the trial data will be used to support US Food and Drug Administration (FDA) approval.
Boston Scientific Cardiology, Rhythm and Vascular Group senior vice president and CMO Keith Dawkins said the Omega Stent will complement their existing portfolio and give interventional cardiologists the option to treat patients with paclitaxel-eluting, everolimus-eluting or bare-metal stents.