Status:
COMPLETED
Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
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 Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coron...
Detailed Description
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as c...
Eligibility Criteria
Inclusion
- Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
- Patients who are eligible for intracoronary stenting
- Age \>18 years, \<75 ages
- 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 :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00997763
Start Date
July 1 2008
End Date
August 1 2015
Last Update
December 13 2016
Active Locations (18)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Busan Saint Mary's Hospital
Busan, South Korea
3
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
4
Cheongju Saint Mary's Hospital
Cheongju-si, South Korea