Tryton Medical has finished enrolling patients in the Tryton Pivotal IDE study, designed to compare the potential of Tryton's Side Branch Stent system with conventional balloon angioplasty in treating bifurcation lesions.
Using a standard single-wire balloon-expandable stent delivery system, the CE-marked cobalt chromium stent is deployed in the side branch followed with 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 has enrolled 704 patients at 67 centres in North America, Europe and Israel, and includes angiographic and intravascular ultrasound (IVUS) substudies.
Patients are randomised 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, according to the company.
The primary endpoint of the study is target vessel failure at nine months, while the secondary endpoint is percent diametre stenosis at nine months in the side branch vessel.
Columbia University Medical Center, Center for Interventional Vascular Therapy director and professor of medicine, and Cardiovascular Research Foundation founder and chairman Dr 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 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," Leon said.
"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 revascularisation of 4% and thrombosis of 0.5% at one year.
"We are looking to corroborate this positive registry data in the Tryton Medical randomised controlled study," McCarthy said.