2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the ratio of the malapposed strut
研究概览
简要总结
The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.
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 (Investigator)
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
- •Patient is ≥ 20 years old
- •Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
- •Patients with stable angina who are considered for coronary revascularization with stent implantation.
- •Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
排除标准
- •Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- •Reference vessel diameter < 2.5 mm or > 4.0mm and lesion length > 28 mm
- •Heavy calcified lesions (definite calcified lesions on angiogram)
- •Lesions requiring more than 2 DES in each vessel
- •Acute coronary syndrome
- •Contraindication to anti-platelet agents
- •Treated with any DES within 3 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
研究组 & 干预措施
P-E group
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
干预措施: Promus Element everolimus eluting coronary stent (Device)
X-P group
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
干预措施: Xience Prime everolimus eluting coronary stent (Device)
结局指标
主要结局
the ratio of the malapposed strut
时间窗: Participants will be followed from first OCT invervention to 3month OCT following intervention
The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I
次要结局
- Incidence of stent malapposition(3months OCT following intervention)
- Neointimal coverage(ANCHOR II)(3 month-OCT after stent implantation)
- Incidence of plaque prolapse(final postprocedural OCT)
- Evaluation of stent expansion(an immediate and post-procedural OCT)
- Stent malapposition(on 3 month OCT intervention)