Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

Inclusion Criteria:

• De novo bifurcation lesions following the Medina classification except (0,0,1).

• Maximum one bifurcation lesion per patient.

• Single bifurcation lesion per vessel.

• The patient is at least 18 years of age. The patient has clinical evidence of ischemicheart disease, stable or unstable angina, silent ischemia, or a positive functionaltrial.

• The patient is an acceptable candidate for percutaneous transluminal coronaryangioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG)surgery.

• The patient or patient's legal representative has been informed of the nature of thetrial and agrees to its provisions and has provided written informed consent asapproved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respectiveclinical site.

• The patient agrees to return to the same research facility for all requiredpost-procedure follow-up visits.

Exclusion Criteria:

• De novo bifurcation lesion Medina (0,0,1).

• Left main bifurcation.

• Heavily calcified lesions.

• Severe tortuous lesions.

• Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.

• Women of childbearing potential.

• Chronic total occlusion (CTO).

• Previous PCI of the target lesion.

• Second lesion requiring treatment in target vessel.

• Second bifurcation lesion requiring treatment.

• Currently participating in an investigational drug or another device trial that hasnot completed the primary endpoint or that clinically interferes with the currenttrial endpoints; or requires coronary angiography, IVUS or other coronary arteryimaging procedures.