Boston Scientific announced the completion of patient enrollment in the small vessel and long lesion trials of its PLATINUM clinical program during the American College of Cardiology (ACC) conference in Atlanta this week. The trials are designed to compare the platinum chromium Promus Element everolimus-eluting stent to matched historical control groups of patients treated with the Taxus Express paclitaxel-eluting stent.
The small vessel trial enrolled 94 patients with de novo lesions between 2.25 and 2.50 mm in diameter and equal to or less than 28 mm in length. The long lesion trial enrolled 102 patients with de novo lesions between 24 to 34 mm in length and 2.50 to 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites globally.
The Element is Boston Scientific’s next-generation stent architecture, with a 0.0032 inch strut thickness made from a platinum chromium allow, Jeff LeMaster, vice president for Boston Scientific’s cardiology division, told Cardiovascular Business News.
The platinum chromium architecture also is more radiopaque and stronger than previous generation stents, giving the stent more flexibility and conformability, LeMaster said.
PLATINUM is a pivotal, randomized, controlled clinical trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element Stent. The Natick-Mass.-based Boston Scientific received CE mark for this product in October 2009.