Safety Study to Assess the FEasibility of Use of the TRYTON Bifurcation Coronary Stent System (SAFE-TRY) (SAFE-TRY)

Inclusion Criteria:

General Inclusion Criteria

• Candidate for percutaneous coronary intervention & emergent coronary artery bypass graft surgery
• Clinical evidence of ischemic heart disease or a positive functional study
• Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
• Patient or patient's legal representative provided written informed consent
• Patient agrees to comply with follow-up evaluations

Angiographic Inclusion Criteria

• Target lesion in a single de novo true bifurcation lesion (Medina classification Type 1.1.1; 1.0.1; 0.1.1; 0.0.1) involving a native coronary artery with reference vessel diameter for the proximal main of 2.5 - 5.0 mm, distal main of 2.5 - 5.0 mm, & side branch RVD of 2.5 - 3.5 mm
• Target lesion in main vessel has stenosis of > 50% and <100%
• Syntax score < 32

Exclusion Criteria:

General Exclusion Criteria

• Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
• Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure
• Serum creatinine level >170 micromol/L within 7 days prior to index procedure
• Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes >2X laboratory upper limit of normal in the presence of a confirming cardiac specific biomarker (Troponin I or T)
• Previous stenting anywhere in target vessel
• Percutaneous coronary intervention (PCI) of non-target vessel within 30 days prior to procedure that results in any MAC(C)E event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal
• PCI of non-target vessel within 24 hours prior to procedure
• Planned PCI of the target vessel within 6 months post-procedure
• During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
• Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation
• History of stroke or transient ischemic attack (TIA) within prior 6 months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Concurrent medical condition with life expectancy <12 months
• Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.

Angiographic Exclusion Criteria

• Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
• Target lesion has any of following characteristics:
• Severely calcified
• Evidence of thrombus
• Syntax score ≥33