Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the completion of enrollment in the TRYTON Pivotal IDE trial evaluating the Tryton Side Branch Stent.™
The landmark Tryton pivotal study is an international randomized trial that compares a Tryton stent in the side branch vs. conventional provisional stenting (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 is the first and only randomized IDE pivotal clinical trial to evaluate a dedicated bifurcation stent, has enrolled 704 patients at 67 centers in North America, Europe and Israel. The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent diameter stenosis at nine months in the side branch vessel.
Martin B. Leon, M.D., F.A.C.C., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, and founder and chairman emeritus of the Cardiovascular Research Foundation, serves as principal investigator of the study.