Tryton Medical (Durham, North Carolina) has announced that the FDA issued the company Investigational Device Exemption (IDE) to complete a trial of company’s proprietary Side Branch Stent System™. The cobalt chromium device is designed to treat coronary atherosclerotic lesions occurring at vessel bifurcations. As we reported before, the system has already received marketing approval in Europe.
Some details of the planned trial:
The randomized, 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 primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent 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 study will enroll 700 patients at up to 75 centers in North America and Europe.