Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- neointimal coverage
研究概览
简要总结
There has been little research on neointimal coverage and malapposition after BES implantation using OCT in human coronary artery. Furthermore, specific drug may possibly influence the vascular healing after stent implantation. Therefore, this study will investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 year old
- •In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg
- •When someone is taking Anti-Hypertensive medication
- •If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin
- •Significant coronary de novo lesion (> 70% by quantitative angiographic analysis)
- •Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention.
- •Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
- •Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm
排除标准
- •Contraindication to anti-platelet agents
- •Proximal leison within 15 mm from ostium
- •Creatinine level 2.0 mg/dL or end stage renal disease on dialysis
- •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)
- •Vein graft lesion
研究组 & 干预措施
Cypher group
干预措施: Sirolimus-eluting stent (Device)
ARB group
干预措施: Eposartan 600mg/day after DES implantation (Drug)
Nobori group
干预措施: Biolimus-eluting stents (Device)
Pravastatin group
干预措施: pravastatin 20mg/day after DES implantation (Drug)
Pitivastatin group
干预措施: pitavastatin 2mg/day after DES implantation (Drug)
Non-ARB group
干预措施: Non-ARB /day after DES implantation (Drug)
结局指标
主要结局
neointimal coverage
时间窗: 6month
1. To compare the neointimal coverage on 6-month follow-up OCT according to specific drug treatment in 2 patient subgroups at 6-month after DES implantation. 2. To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation.
次要结局
- stent malapposition and thrombus(6month)