Status:
COMPLETED
Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to establish the safety and long-term effectiveness of coronary stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. the sirolimus-e...
Detailed Description
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
2645 Patients enrolled
Trial Details
Trial ID
NCT00418067
Start Date
October 1 2006
End Date
January 1 2009
Last Update
August 21 2012
Active Locations (20)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Daegu Catholic University Medical Center
Daegu, South Korea
3
Keimyung University Dongsan Medical Center
Daegu, South Korea
4
Kyungpook National University Hospital
Daegu, South Korea