Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report

We report the acute and 30 day results from the Tryton I first-in-man (FIM) study, a multicentre prospective single arm study evaluating the safety and feasibility of the Tryton Side-Branch StentTM when used in conjunction with standard drug eluting stent to treat de novo bifurcation lesions within the coronary vasculature.

Clinically, stable patients with de novo coronary bifurcation lesions with side branch diameters 2.25-2.75 mm were treated. Clinical follow-up at 30 days, 9 months and one year is mandated in all patients. Angiographic and IVUS evaluation is performed at the completion of the case and at 6 months. A total of 30 patients (66.0+/-11.2 years old, 63% male) were treated. Approximately 76% of the treated lesions involved a left anterior descending-diagonal (LAD-Diag), with the remainder of lesions in the left circumflex-obtuse marginal (21%) and right coronary-posterior descending (4%) coronary arteries. Baseline angiographic disease in both main vessel (MV) and side branch (SB) was noted in 50% of patients. In 47% of patients, angiographic disease was limited to the MV, and in one patient (3%) to the SB ostium. Two major major adverse cardiac events (MACE) were noted (94% success Rate). All patients were treated via 6 Fr guides. Angiographic success including final kissing balloon inflation was achieved in all patients in whom the Tryton StentTM could be tracked to the lesion site (97% angiographic success). No additional MACE events were noted between hospital discharge and day 30.

A dedicated two stent strategy utilising the Tryton Side-Branch StentTM to treat bifurcation lesions is feasible showing good acute and 30 day results.