Boston Scientific has begun patient enrollment in the PLATINUM clinical trial, which is designed to evaluate its Promus Element everolimus drug-eluting stent (DES).
The PLATINUM program will enroll 1,728 patients at 160 sites globally. The trial will compare the Promus Element everolimus-eluting coronary stent to the Promus everolimus-eluting coronary stent. The Natick, Mass.-based company said it plans to develop additional variations of the Element stent platform, including next generations of a bare-metal stent and a paclitaxel-eluting Taxus Element stent.
The Element stent platform features a platinum chromium alloy, designed for coronary stents. In addition, the Promus Element stent system incorporates the new Apex dilatation catheter technology, designed for deliverability to complex lesions.
The global principal investigator for the trial is Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation in New York City. The U.S. co-principal investigator is Paul Teirstein, MD, of Scripps Green Hospital in La Jolla, Calif., and the international co-principal investigator is Ian Meredith, MD, PhD, director of cardiology at the Monash Medical Centre in Melbourne, Australia.
Thomas Downes, MD, of the Medical Center of the Rockies in Loveland, Colo., enrolled the first U.S. patient and the firm said the first Japanese patient was enrolled last week.