Tryton Medical (Durham, NC), which develops stents for treating coronary artery bifurcation lesions, will begin a clinical trial using the company's Tryton Side Branch Stent, with evaluation by intravascular optical coherence tomography (OCT) imaging technology. The Nordic-Baltic Dedicated Bifurcation Trial, which will involve 150 patients, will examine the role of final kissing balloon inflations in patient outcomes.
Related: Totally tubular: Cardiovascular OCT goes prime time
The trial is the latest investigation from the Study Group, which has a history of examining different techniques for treating bifurcation lesions in the Nordic I, II, III, and IV studies. The publications associated with these studies are among the most frequently cited by interventional cardiologists.
The Tryton Side Branch Stent is supported by clinical evidence in more than 1,000 patients. Published data in a patient pooled analysis from more than 900 patients treated with the Tryton Side Branch Stent in more than eight European post-marketing registries demonstrated low target lesion revascularization rates of 2.9 percent at six months and 4.0 percent at one year, and a low 0.5 percent thrombosis rate at one year. More than 7,500 patients have been treated with the stent, which is available commercially throughout Europe, Russia, and the Middle East.
The company has completed enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent, and anticipates study outcomes will be presented at the Transcatheter Cardiovascular Therapeutics 2013 (TCT 2013) conference, to take place October 27 through November 1, 2013, in San Francisco, CA.
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