Status:
COMPLETED
Comparison of Neointimal Coverage Between Zotarolimus Eluting Stent and Everolimus Eluting Stent
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
Stent thrombosis is an important issue in drug eluting stents. Incomplete endothelial coverage and neointimal coverage over strut after drug eluting stent (DES) implantation could be a possible cause ...
Detailed Description
Recent autopsy study showed the most important histological and morphometric predictors of stent thrombosis were endothelial coverage and the ratio of uncovered to total strut after drug eluting stent...
Eligibility Criteria
Inclusion
- Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
- Patients with stable or acute coronary syndrome considered for coronary revascularization
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion
- The criteria for exclusion were contraindication to anti-platelet agents
- Proximal lesion within 15 mm from ostium
- Different DES in other vessel simultaneously
- Creatinine level 2.0 mg/dL or ESRD
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy 1 year
- Complex lesion morphologies (aorto-ostial, bifurcation with \> 2.0 mm side branch, unprotected left main, thrombus, severe calcification, chronic total occlusion)
- Target lesion is vein graft lesion
- Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
- Long lesion that require more than two stents
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00894062
Start Date
December 1 2008
Last Update
March 24 2010
Active Locations (3)
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1
Dongsan Medical Center, Keimyung University
Daegu, South Korea, 700-712
2
Severance Hospital, Yonsei University
Seoul, South Korea, 120-752
3
Samsung Medical Center
Seoul, South Korea, 135-710