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Kaplan AV, Ramcharitar S, Louvard Y, et al. Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report. EuroIntervention. 2007;3(1):54-9
Kaplan, A. V., Ramcharitar, S., Louvard, Y., Müller, R., Davis, H. R., Morice, M. C., Serruys, P. W., & Grube, E. (2007). Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 3(1), 54-9.
Kaplan, Aaron V, et al. "Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report." EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology vol. 3,1 (2007): 54-9.
Kaplan AV, Ramcharitar S, Louvard Y, Müller R, Davis HR, Morice MC, Serruys PW, Grube E. Tryton I, First-In-Man (FIM) Study: acute and 30 day outcome.A preliminary report. EuroIntervention. 2007 May;3(1):54-9. PMID: 19737685.
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EuroIntervention. 2007 May;3(1):54-9.

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

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

Aaron V Kaplan, Steve Ramcharitar, Yves Louvard, Ralf Müller, H Richard Davis, Marie-Claude Morice, Patrick W Serruys, Eberhard Grube

Affiliations

  1. Cardiology Section, Dartmouth Medical School/Dartmouth-Hitchcock Medical Center, Hanover NH, USA.

PMID: 19737685

Abstract

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.

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