Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries

Inclusion Criteria include all of the following:

   - Subject is ≥ 18 years old

   - Subject is eligible for percutaneous coronary intervention (PCI) and has a single
   lesion requiring treatment

   - Subject is an acceptable candidate for CABG

   - Clinical evidence of ischemic heart disease or a positive functional study

   - Documented stable angina pectoris

   - The target lesion is a single de novo coronary artery lesion with ≥50 and <100%
   stenosis by visual estimate

Exclusion Criteria include all of the following:

   - Female of childbearing potential. Female subjects must be medically or surgically
   sterile or diagnosed as post-menopausal (i.e. one year since final menstrual cycle.

   - Evidence of an acute myocardial infarction and/or CK-MB>2x upper limit of normal
   within 72 hours of the intended treatment

   - Known allergies to the following: aspirin, clopidogrel (Plavix) or ticlopidine
   (Ticlid), heparin, stainless steel, tantalum, contrast agent (that cannot be
   adequately premedicated), paclitaxel or drugs similar to zotarolimus (ABT-578) (i.e.
   tacrolimus, sirolimus, everolimus)

   - A platelet count <100,000 cells/mm3or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or
   hemoglobin <10.0g/dL

   - Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150µmol/L)

   - Subject has had any previous or planned brachytherapy in the target vessel