October 7, 2011 — Boston Scientific Corp. has started patient enrollment in the Omega clinical trial, designed to evaluate the company's Omega platinum chromium bare-metal coronary stent system. The trial will test the safety and effectiveness of OMEGA in treating patients with a single coronary artery lesion.
This prospective, single-arm trial will enroll 328 patients at 40 sites in the United States and Europe. The first patient was enrolled this week by Prof. 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, Md.; and Prof. Christian Hamm, M.D., of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.
The primary endpoint of the 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 U.S. Food and Drug Administration (FDA) approval.
The Omega stent system is part of Boston Scientific's platinum chromium (PtCr) stent series, which includes the Ion paclitaxel-eluting stent system and the Promus Element everolimus-eluting etent system. These stents feature the novel PtCr alloy and an innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The higher density alloy provides enhanced visibility while permitting thinner struts compared to prior-generation Boston Scientific stents.
The Omega stent received CE Mark approval in March 2011. It is offered in 48 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths from 8 mm to 32 mm. The company received CE Mark approval for the Promus Element in October 2009 and for the Taxus Element in May 2010. The Ion received FDA approval in April 2011
In the United States and at participating EU clinical sites, the Omega stent system is an investigational device, limited by applicable law to investigational use and not available for sale.
For more information: www.bostonscientific.com