Status:
COMPLETED
Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Brief Summary
Neointimal coverage over stent strut is important for preventing the stent thrombosis. But, there is no data for the duration of complete formation of neointima om zotarolimus eluting stent (ZES). Pre...
Detailed Description
Stent thrombosis is current main issue after introduction of drug-eluting stents and theoretically dual antiplatelet therapy should be continued to prevent the stent thrombosis until complete reendoth...
Eligibility Criteria
Inclusion
- Significant coronary de novo lesion ( \> 70% by quantitative angiographic analysis)
- Patients with stable or acute coronary syndrome considered for coronary revascularization.
- Non-emergent conditions
- Reference vessel diameter of 2.75 to 4.0 mm by operator assessment
Exclusion
- The criteria for exclusion were contraindication to anti-platelet agents
- ST elevation MI requiring primary PCI
- Proximal lesion within 15 mm from ostium
- Prior insertion of other DES in any vessel
- Creatinine level more than 2.0mg/dL or ESRD
- Severe hepatic dysfunction (more than 3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy less than 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 estimation
- Long lesion that require more than two stents
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00815139
Start Date
February 1 2008
Last Update
December 29 2008
Active Locations (1)
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1
Division of Cardiology, Cardiovascular Hospital, Yonsei University
Seoul, South Korea, 120-752