Tryton Medical has announced the completion of enrolment in the Tryton pivotal investigational device (IDE) exemption trial evaluating the Tryton Side Branch Stent.
The Tryton pivotal study is an international randomised 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 utilising a standard drug-eluting stent in the main vessel.
The study has enrolled 704 patients at 67 centres 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, 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.
“Completion of patient recruitment is a major milestone for the Tryton IDE pivotal trial, which is truly a landmark study. In addition to being the first powered randomised controlled trial evaluating a dedicated side branch stent, it is the largest coronary bifurcation study ever attempted and the first one to have core angiographic (3D and planar) and IVUS sub-studies. The results of the Tryton study will directly guide the treatment of patients with complex bifurcation disease,” said Leon. “Our current inability to treat these lesions with ‘work horse’ drug-eluting stents, represents an important unmet clinical need which confronts interventional cardiologists. From my travels to Europe and Israel, I have been impressed with how easily the Tryton tent is incorporated into routine practice. We look forward to results from this trial.”
“Tryton Medical’s differentiated technology addresses the challenges of bifurcated lesions, which affect nearly a third of patients undergoing a percutaneous coronary intervention procedures. Data from more than 1,000 registry patients in Europe treated with the Tryton stent are already challenging provisional stenting, with compelling results of target lesion revascularisation of 4% and thrombosis of 0.5% at one year,” said Shawn P McCarthy, president and CEO of Tryton Medical. “We are looking to corroborate this positive registry data in the Tryton Medical randomised controlled study. With more than 6,000 implants to date, we are leveraging our impressive data to further expand globally. We are on track to be the first and only approved stent for coronary bifurcations in the USA”
The stent system has received CE mark and is commercially available throughout Europe, Russia and the Middle East. It is approved in the United States for investigational use only.