The FDA has granted conditional approval for Tryton Medical’s investigational device exemption application to initiate the pivotal trial to evaluate the Tryton side branch stent system for the treatment of coronary artery disease.
Martin B. Leon, MD, professor of medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York City, and founder of the Cardiovascular Research Foundation, will serve as principal investigator of the study.
The randomized, controlled study will compare the use of the Tryton stent in the side branch in conjunction with a standard drug-eluting stent in the main vessel versus the use of angioplasty in the side branch with a standard drug-eluting stent in the main vessel for the treatment of complex bifurcation disease, the company said. 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 as assessed in an angiographic subgroup.
Approximately 374 patients will undergo angiographic follow-up at nine months, according to Durham, N.C.-based Tryton. The study also will include an intravascular ultrasound (IVUS) sub-study in 96 patients with IVUS follow-up at nine months. The study will seek to enroll 700 patients at up to 75 centers in North America and Europe.