Boston Scientific has started patient enrolment in the OMEGA clinical trial, designed 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.
This prospective, single-arm trial will enrol 328 patients at 40 sites in the USA and Europe. The first patient was enrolled on the first week of October by Andrejs Erglis, OMEGA principal investigator, at Paul Stradins Clinical University Hospital in Riga, Latvia. The trial’s coordinating principal investigators are John Wang, Union Memorial Hospital in Baltimore, Maryland, USA, and Christian Hamm, Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.
“I am enthusiastic about enrolling patients in the OMEGA trial and the potential this advanced bare-metal stent platform holds as a treatment option for patients with coronary artery disease,” said Wang. “The new alloy and design of the Omega stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy.”
The primary endpoint of the OMEGA trial is nine-month target lesion failure, a composite measure that includes target lesion revascularisation, myocardial infarction and cardiac death. Target lesion failure 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.
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 stent system. This family of stents features 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.
In the USA 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.