Bare Metal Bifurcation Stent Clinical Trial in Humans

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 ia a single de novo bifurcation lesion involving a native coronary artery with reference vessel diameter for the proximal main of 3.8 - 4.3 mm, distal main of 3.0 - 3.5 mm, & side branch RVD up to 2.5 mm
• Acceptable target lesion lengths are any combination of:
• 50% and 2

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 700, 000 cells/mm³, or a white blood cell (WBC) count 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 with presence of elevated CK-MB (any amount above laboratory upper limit of normal)
• Previous stenting anywhere in target vessel
• PCI of non-target vessel within 30 days prior to procedure that results in any MACE 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 any vessel within 30 days post-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) 90 degrees by visual estimate
• Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
• Significant stenosis (>50%) proximal or distal to target lesion that might require revascularization or impede run off.
• Target vessel is excessively tortuous (two bends >90º to reach target lesion)
• Target lesion has any of following characteristics:
• Lesion location is aorto-ostial, unprotected left main lesion, or within 5 mm of origin of left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA).
• Severely calcified
• Evidence of thrombus
• Co-existence of unprotected left main coronary artery disease (obstruction >50% in left main coronary artery)