Trial Search Results
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.
Stanford is currently not accepting patients for this trial.
Abbott Medical Devices
- Device: ZoMaxx™ Drug-Eluting Coronary Stent System
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study