The CE-marked cobalt chromium stent uses a standard single-wire balloon-expandable stent delivery system for the deployment in the side branch and the placement of a conventional drug-eluting stent in the main vessel.

In addition, the device is built with a proprietary Tri-zone technology and addresses the challenges of bifurcated lesions, which affect nearly a third of patients undergoing a PCI procedure.

The international IDE trial, which has enrolled 704 patients at 67 centers in North America, Europe and Israel, is designed to compare the potential of Tryton Side Branch Stent system with conventional balloon angioplasty.

Patients are randomized to receive Tryton stent and balloon angioplasty in the side branch, while both arms will receive a standard drug eluting stent in the main vessel.

The primary endpoint of the study is target vessel failure at nine months, while the secondary endpoint is percent diameter stenosis at nine months in the side branch vessel.

Center for Interventional Vascular Therapy director and medicine professor and Cardiovascular Research Foundation founder and chairman Martin Leon said the results of the Tryton study will directly guide the treatment of patients with complex bifurcation disease.

"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 (3D and planar) and IVUS sub-studies," Leon added.

"We look forward to results from this trial."

Tryton Medical president and CEO Shawn McCarthy said data from more than 1,000 registry patients in Europe treated with the Tryton stent has shown the target lesion revascularization of four percent and thrombosis of 0.5 percent at one year.

"We are looking to corroborate this positive registry data in the Tryton Medical randomized controlled study," McCarthy added.