NCT02232815Unknown不适用
A Randomized Multicentre Trial to Compare Outcomes for Patients With Ischaemic Heart Disease and Bifurcation Coronary Artery Lesions Who Are Treated With Xience or Synergy Stents
European Cardiovascular Research Center6 个研究点 分布在 2 个国家目标入组 170 人开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Composite measure of Adverse events
研究概览
简要总结
This study will examine outcomes for patients treated by planned culotte stenting and compare outcomes with 2 different stent platforms, the next generation Synergy II and the Xience Xpedition DES platforms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient >18 years old
- •Females of childbearing potential with a negative pregnancy test
- •Coronary artery disease requiring revascularization that is amenable to PCI
- •Medina 1,1,1 bifurcation lesion [13] with >70% lesion in both the main vessel and the side branch by visual assessment
- •Main branch and side branch ≥ 2.5mm in diameter by visual assessment
- •Both vessels require stenting in the opinion of the operator
排除标准
- •Acute myocardial infarction with ongoing ST-elevation
- •Cardiogenic shock
- •Lesion involves the left main coronary artery
- •Lesion involves bypass graft
- •Plan to treat >1 other coronary vessel at the time of inclusion
- •Chronic total occlusion of any target vessel
- •Left ventricular ejection fraction <20%
- •Requirement for ongoing haemodialysis
- •Life-expectancy limited to <12 months due to co-morbid condition
- •Known allergy to Aspirin
- •Known allergy to Clopidorel and Prasugrel and Ticagrelor
- •Known allergy to stent drug elutant
- •Known allergy to any other component of either the Synergy II or Xience Xpedition stents systems
- •Ongoing participation in another investigational device or drug study
- •Inability to provide informed consent
结局指标
主要结局
Composite measure of Adverse events
时间窗: 9 months
Composite of: * Death * Myocardial Infarction * CVA * Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy) * Definite or Probable stent thrombosis (ARC criteria \[14\]) * Binary angiographic restenosis
次要结局
- Need to use secondary equipment or manoeuvres to complete the case(Day 0, during procedure)
- Evidence of longitudinal stent compression at index implantation(Day 0, during procedure)
- Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)(Day 0, during procedure)
- Total procedure time(Day 0, during procedure)
- Total radiation dose(Day 0, during procedure)
- Evidence of stent fracture at angiographic follow-up(Day 0, during procedure)
- Composite measure of Adverse events(24 months)
研究者
研究点 (6)
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