Tryton Medical, a developer of stents designed to treat bifurcation lesions, announced that the first patient has been enrolled in the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.
Indulis Kumsars, chief of the catheterisation laboratory at Pauls Stradins Clinical University Hospital in Riga, Latvia, enrolled the first patient.
“Our team is very excited and happy to participate in this first substantial randomised trial of the Tryton bifurcation device. We look forward to gaining a better understanding of the role of a dedicated bifurcation stent in the optimal treatment of these lesions,” said Kumsars.
“The enrolment of the first patient in the study is yet another milestone for Tryton in what has been a very exciting year for the company,” said J Greg Davis, president and CEO of Tryton Medical. “We have gained significant momentum in 2010 – from launching our innovative product across Europe and the Middle East to a successful fundraising event. We look forward to rapid enrolment in the pivotal study and growing product adoption internationally in 2011.”
The randomised, 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 vs. 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 study will enrol 704 patients at up to 75 centres in North America and Europe. The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is per cent 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. The study will also include an IVUS substudy in 96 patients with IVUS follow-up at nine months.
The stent system has received CE mark approval in Europe and is commercially available in 21 countries throughout Europe and the Middle East. It is not approved in the United States.