Tryton's Side Branch Stent Pivotal Study Completes Enrollment

November 26, 2012—Tryton Medical, Inc., (Durham, NC) announced the completion of enrollment in the pivotal TRYTON trial that is evaluating the Tryton side branch stent through an investigational device exemption (IDE) from the US Food and Drug Administration.

According to the company, the landmark TRYTON pivotal study is an international randomized trial that compares a Tryton stent in the side branch versus conventional provisional stenting via balloon angioplasty in the side branch, with both arms of the trial utilizing a standard drug-eluting stent in the main vessel. The study has enrolled 704 patients at 67 centers in North America, Europe, and Israel. The primary endpoint of the study is target vessel failure at 9 months. A secondary endpoint is percent diameter stenosis at 9 months in the side branch vessel.

Martin B. Leon, MD, of the Center for Interventional Vascular Therapy at Columbia University Medical Center and the Cardiovascular Research Foundation in New York City, serves as principal investigator of the study. Patrick W. Serruys, MD, of the Thoraxcenter at Erasmus Medical Center in Rotterdam, The Netherlands, is leading the intravascular ultrasound (IVUS) and three-dimensional angiographic analysis.

“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 randomized 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 (three-dimensional and planar) and IVUS substudies,” Dr. Leon stated in Tryton's press release. “The results of the Tryton study will directly guide the treatment of patients with complex bifurcation disease. 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 stent is incorporated into routine practice. We look forward to results from this trial.”

According to the company, the Tryton side branch stent system incorporates Tryton's Tri-zone technology for treating bifurcation lesion. Tryton's cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. The stent system has received CE Mark approval and is commercially available throughout Europe, Russia, and the Middle East. It is approved in the United States for investigational use only.