Status:
COMPLETED
Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study
Lead Sponsor:
Yonsei University
Conditions:
Multi-vessel Diseases, Angina
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted...
Eligibility Criteria
Inclusion
- Patient is ≥ 20 years old
- Patients with typical angina who are considered for coronary revascularization.
- Multi-vessel diseases: more than 2 significant coronary de novo lesions (\> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.
Exclusion
- ST-elevation MI
- Cardiogenic shock or hemodynamically unstable status
- Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
- Contraindication to anti-platelet agents
- Treated with any DES within 6 months at other vessel
- 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 (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01856374
Start Date
August 1 2011
End Date
October 1 2014
Last Update
July 27 2016
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752