title: Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions.
abstract: OBJECTIVE
  To report clinical and angiographic follow-up at 6 months after implantation of the Tryton Side-Branch Stent dedicated to bifurcation, in conjunction with standard workhorse drug-eluting stent (DES).
  
  
  RESULTS
  Patients having angina or silent myocardial ischaemia with de novo bifurcation lesions were enrolled at three sites. The Tryton stent was first placed in the side-branch and a standard DES subsequently implanted in the main-branch. The primary endpoint was freedom from in-hospital major adverse cardiac events (MACE) following procedural success. Angiographic and clinical follow-up was performed at 6-months. Quantitative coronary angiography (QCA) was analysed with a new dedicated bifurcation software. Thirty patients were enrolled. At six months clinical follow-up was available in 100% with angiographic follow-up performed in 78%. The primary endpoint was met in 93.3%. The MACE rate at 6 months was 9.9%. QCA analysis demonstrated late luminal loss of 0.17 mm with no restenosis in the side branch.
  
  
  CONCLUSIONS
  In conjunction with a workhorse DES to treat bifurcation lesions, the Tryton side-branch stent demonstrated acceptable clinical outcome and low side-branch late loss at six months.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.forename: Steve
authors.initials: S
authors.lastname: Ramcharitar
authors.forename: Robert-Jan M
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Yves
authors.initials: Y
authors.lastname: Louvard
authors.forename: Marie-Angèle
authors.initials: MA
authors.lastname: Morel
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Richard
authors.initials: R
authors.lastname: Davis
authors.forename: Aaron V
authors.initials: AV
authors.lastname: Kaplan
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys