Status:
COMPLETED
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-inf...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT00140101
Start Date
May 1 2005
End Date
January 1 2012
Last Update
January 10 2012
Active Locations (92)
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1
Huntsville Hospital
Huntsville, Alabama, United States, 35801
2
ACS-Mesa General Hospital
Gilbert, Arizona, United States, 85233
3
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
4
Scripps Memorial Hospital
La Jolla, California, United States, 92037