drugset / Trial / NCT01856374

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

NCT01856374

Phase 4 Completed 60 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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 DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.

Timeline

Start
2011-08
Primary completion
2014-03
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg
Comparator Pravastatin Small molecule 20 mg