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

Coronary artery disease is the major cause of morbidity and mortality in the United States. The American Heart Association estimates that 571,000 Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures were performed in 2001 in the United States and that 80% to 90% of these patients also underwent stent placement. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 to 35% in-stent restenosis occurs within 6 to 9 months after stent placement. While stents can reduce restenosis by blocking vascular recoil and remodeling, mechanical intervention alone is incapable of treating the biological problem of neointimal hyperplasia. Various approaches have been used to treat in-stent restenosis, including balloon angioplasty, repeat stenting, rotational and directional atherectomy, laser, and local delivery of radiation at the time of stenting (brachytherapy). However, these techniques add complexity to the interventional procedure and have not had documented success in preventing in-stent restenosis. Drug-eluting stents (DES) using antiproliferative agents delivered via a polymer based stent platform have shown significant success in the reduction of restenosis in de novo lesions over the traditional bare metal stents in randomized clinical trials. Local delivery of the pharmacological agent allows for controlled delivery of high drug concentrations to the targeted tissue while minimizing systemic drug effects. The ZoMaxx II Trial represents the first US study of the ZoMaxx(TM) Drug Eluting Coronary Stent System to evaluate the potential benefits of the local application of the zotarolimus drug in combination with a phosphorylcholine (PC)-coated tri-metal stent.

ZoMaxx™ Drug-Eluting Stent System is an Investigational device. Limited by Federal (U.S.) law to investigational use only.

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

• Device: ZoMaxx™ Drug-Eluting Coronary Stent System
  Drug eluting stent implantation stent in the treatment of coronary artery disease.
• Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
  Drug eluting stent implantation stent in the treatment of coronary artery disease.

• Experimental: 1
  ZoMaxx™ Drug-Eluting Stent System
  Intervention: Device: ZoMaxx™ Drug-Eluting Coronary Stent System
• Active Comparator: 2
  TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
  Intervention: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

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