Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up
研究概览
简要总结
The primary objective of this study is:
- comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups.
The secondary outcomes are a comparison of (using OCT):
- number of uncovered stent struts
- number of malapposed stents struts
- in-stent neointimal volume
- in-segment assessment of vessel wall response to DES
详细描述
The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI within 12 hours from symptoms onset
- •Native coronary disease with a lesion suitable for stenting
- •Vessel size in between 2.5-3.75mm
- •Patient is willing to provide written informed consent
- •Male or female patients between 18-85 years of age
排除标准
- •Significant left main disease
- •Killip class IV
- •Known allergy to aspirin and or clopidogrel/ticlopidine
- •Recent bleeding (<1month)
- •Patient in anticoagulant therapy
- •No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel />3.75mm in diameter/)
- •Severe liver or renal disease (Cr>2.0)
- •Life expectancy < 1 year
结局指标
主要结局
to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up
时间窗: 2 years
次要结局
- number of uncovered stent struts(2 years)
- number of malaposed stents struts(2 years)
- in-stent neointimal volume(2 years)
- in-segment assessment of vessel wall response to DES(2 years)