Tryton Medical has announced enrolment of the first patient in E-Tryton 150, a registry study of the company’s Tryton Side Branch Stent System. E-Tryton 150 is one of four registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings.
The Tryton Side Branch Stent is designed to offer a dedicated strategy for treating atherosclerotic lesions at the site of a bifurcation. Current approaches to treating these lesions have significant limitations. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation.
“I am thrilled to participate in E-Tryton 150,” said Dr Eulogio Garcia. “Early data for the Tryton Side Branch Stent System is very promising, and we hope to confirm these excellent results in patients with bifurcation disease in real-world hospital settings. The Tryton Stent is easy to use and we are happy to start using it in our daily clinical practice.”
The E-Tryton 150 registry will enrol 150 patients in several European sites. The primary endpoint of the study is the overall rate of major adverse cardiac events (MACE) at six months following the procedure. MACE is defined as cardiac death, myocardial infarction and target lesion revascularisation (main and/or side branch). The study will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularisation (TLR) at six months after the procedure.
The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. Approximately 20% of patients treated for coronary artery disease are treated for bifurcated lesions. The Tryton Side Branch Stent System received CE mark approval in February 2008.
Tryton’s highly deliverable cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.
The Tryton Side Branch Stent System demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side-branch artery. The stent system has received CE Mark approval in Europe and is not approved in the United States.
The Tryton Side Branch Stent System is used in conjunction with a conventional drug-eluting stent.