Status:
COMPLETED
Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coron...
Detailed Description
Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by...
Eligibility Criteria
Inclusion
- Diabetic patients with angina and documented ischemia
- Patients who are eligible for intracoronary stenting
- De novo lesion
- Percent diameter stenosis ≥50%
- Reference vessel size ≥ 2.5 mm by visual estimation
Exclusion
- History of bleeding diathesis or coagulopathy
- Pregnant state
- Known hypersensitivity or contra-indication to contrast agent and heparin
- Limited life-expectancy (less than 1 year)
- Acute ST elevation myocardial infarction on admission
- Characteristics of lesion Left main disease In-stent restenosis Graft vessels
- Hematological disease (Neutropenia \<3000/mm3, Thrombocytopenia \<100,000/mm3)
- Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
- Renal dysfunction, creatinine ≥ 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- Left ventricular ejection fraction \<30%
- Patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period.
- 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).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01186107
Start Date
August 1 2010
End Date
July 1 2013
Last Update
July 29 2014
Active Locations (11)
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1
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
2
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
3
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
4
Kangwon University Hospital
Chuncheon, South Korea