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:
- <16mm proximally from carina in proximal main vessel
- <16mm distally from the carina in distal main branch
- <12mm from carina in side branch
- Target lesion in main vessel has stenosis of > 50% and <100%
- Target vessel has (TIMI) flow >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 <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 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) <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
- Bifurcation angle of >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)