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