Tryton Pivotal (RCT and Confirmatory Results)

Pivotal Trial Demonstrated Superior Acute and Long-Term Patency Over Provisional Stenting

The landmark Tryton IDE study was a multi-national randomized trial that compared a Tryton stent in the side branch vs. the use of balloon angioplasty in the side branch, with both arms of the trial utilizing a standard drug eluting stent in the main vessel. The study, which was the first and only randomized IDE clinical trial of a bifurcation stent, enrolled over 700 patients from up to 75 centers in North America, Europe and Israel. Martin Leon, M.D. (Columbia University, New York) served as principal investigator for the study and Patrick Serruys, M.D., PhD. (Thoraxcenter, Rotterdam) led the IVUS.