Tryton Medical has completed patient recruitment in the intravascular ultrasound (IVUS) group of the Tryton IDE Study, investigating the Tryton side branch stent, built on its Tri-zone technology for treating bifurcation lesions.
The randomised controlled study has so far enrolled 175 patients, and is expecting to enroll 704 in total of which 400 will undergo angiographic follow up at nine months.
The trial compares a Tryton stent in the side branch to the use of balloon angioplasty in the side branch. Both arms of the trial utilise a standard drug eluting stent in the main vessel.
The primary endpoint of the study is target vessel failure, while the secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup.
The company said results of the study will be submitted to the US Food and Drug Administration (FDA) for receiving marketing approval.
Currently the stent system is commercially available throughout Europe, Russia and the Middle East.