January 26, 2011 – Patient enrollment has begun in China for a trial evaluating the safety and effectiveness of a next-generation stent. The PLATINUM China clinical trial will look at the Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent, by Boston Scientific, for treating patients with a single de novo atherosclerotic lesion.
The trial will compare the company’s stent to its Taxus Liberte Paclitaxel-Eluting Coronary Stent. The prospective, randomized trial will enroll 500 patients at 15 sites in China. The first patient was enrolled this week at Shenyang Northern Hospital by Yaling Han, M.D., the co-principal investigator of the trial. The other co-principal investigator is Runlin Gao, M.D., of the Cardiovascular Institute and Fu Wai Hospital in Beijing.
"I am enthusiastic about the start of enrollment in the PLATINUM China trial and for the potential of this advanced stent platform as a treatment option for my patients with coronary artery disease," Gao said. "The new alloy and stent design of the Promus Element Stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy."
The stent features a platinum chromium alloy and design that combine to offer greater radial strength and flexibility while reducing stent recoil. The stent geometry helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density platinum chromium alloy provides superior visibility while permitting thinner struts compared to prior-generation stents.
The company received CE Mark approval for the Promus Element Everolimus-Eluting Stent System in October 2009 and for the Taxus Element Paclitaxel-Eluting Stent System in May 2010. Both systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.
The company expects U.S. Food and Drug Administration approval for the Taxus Element Stent System in mid 2011 and for the Promus Element Stent System in mid 2012. In Japan, the company expects approval for the Taxus Element Stent System in late 2011 or early 2012 and for the Promus Element Stent System in mid 2012.
For more information: www.bostonscientific.com