Tryton Medical has enrolled first US patient in a clinical trial to evaluate the Tryton Side Branch Stent System as a treatment for coronary artery disease.
The randomised, controlled study will compare the use of Tryton stent in the side branch and a standard drug eluting stent in the main vessel versus angioplasty in the side branch and a standard drug eluting stent in the main vessel for the treatment of coronary artery disease.
The study will enroll 704 patients across 75 centres in North America and Europe.
The primary endpoint of the study will be target vessel failure at nine months, while the secondary endpoint will be percent diameter stenosis at nine months in the side branch vessel as evaluated in an angiographic subgroup.
The Tryton Side Branch Stent System has received European CE mark approval, and is approved in the US for investigational use only.