Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions (ZEST)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Stent
Eligibility Criteria
Inclusion Criteria:
- The patient must be at least 18 years of age.
- Significant coronary artery stenosis (>50% by visual estimate)
- Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
• Heparin, Aspirin, Both Clopidogrel and Ticlopidine, Sirolimus, paclitaxel, ABT 578, Stainless steel and/or Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 12 months post enrollment.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Patients who have target lesion of in-stent restenosis at the stented segment of drug-eluting stent (in-stent restenosis of bare metal stent can be included).
- Patients with EF<30%.
- Patients with cardiogenic shock
- Acute STEMI patients within symptom onset < 12 hours needing primary angioplasty
- Creatinine level > 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT > 3 times upper normal reference values).
- Patients with left main stem stenosis (>50% by visual estimate)
Sites / Locations
- Soonchunhyang University Bucheon Hospital
- Daegu Catholic University Medical Center
- Keimyung University Dongsan Medical Center
- Kyungpook National University Hospital
- Chungnam National University Hospital
- Asan Medical Center
- Chonnam National University Hospital
- NHIC Ilsan Hospital
- Chonbuk National University Hospital
- Pusan Natioanal University Hospital
- Hallym University Sacred Heart Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- Korea University Hospital
- Seoul National University Hospital
- St.Mary's Catholic Medical Center
- Yonsei University Medical Center
- Ajou University Hospital
- Ulsan University Hospital
- Yonsei University Wonju Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Cypher
Taxus Liberte
Endeavor
Sirolimus-eluting stent
Paclitaxel-eluting stent
Zotarolimus-eluting stent