Boston Scientific has initiated Platinum Plus clinical trial, an investigator-sponsored research (ISR) study designed to compare the performance of the Promus Element Everolimus-Eluting Coronary Stent System with the Xience Prime Everolimus-Eluting Coronary Stent System.
The Promus Element Stent, which received CE mark in October 2009, is Boston Scientific’s third-generation drug-eluting stent technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system.
Platinum Plus is a prospective, randomized, multi-center clinical trial with planned enrollment of 2,980 patients at 50 sites in France, Germany, Italy, Spain and the UK.
It will evaluate coronary revascularization outcomes in an unrestricted patient population randomized (2:1) to receive a Promus Element Stent or Xience Prime Stent. The primary endpoint is 12-month target vessel failure with planned follow-up out to 34 months.
The Promus Element Stent is designed specifically for coronary stenting. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility.
Boston Scientific claimed that the stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents.
The Platinum Plus trial is coordinated by the Centre Europeen de Recherche Cardiovasculaire (CERC) under the direction of Marie-Claude Morice. CERC is an interventional cardiology clinical research organization based in Paris.
Marie-Claude Morice, trial co-ordinator, said: “This is an important study that could provide insights on the potential benefits of third-generation drug-eluting stents in an all-comers trial reflecting the daily clinical practice of interventional cardiologists.”
The Platinum Plus trial will provide data that may complement Boston Scientific’s Platinum clinical trial, which completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Platinum is a randomized, controlled, pivotal trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the Promus Element Stent System.
In the US, the Promus Element and TAXUS Element Stent Systems are investigational devices and are limited by applicable law to investigational use only and are not available for sale.