NCT03058627进行中（未招募）不适用
Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial
Thomas Engstrom14 个研究点 分布在 4 个国家目标入组 454 人开始时间: 2017年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 454
- 试验地点
- 14
- 主要终点
- All-cause mortality, myocardial infarction, or urgent revascularization
研究概览
简要总结
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
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
- None
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
- •Age ≥ 18 years
- •Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
- •At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter
排除标准
- •Life expectancy < 1 year due to other severe non-cardiac disease
- •Severe renal failure with estimated glomerular filtration rate < 20 ml/min
- •No PCI-eligible coronary artery stenosis, but rotablation is allowed
- •Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
- •Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
- •Only stenoses with thrombolysis in myocardial infarction grad < 3
- •Potential pregnancy
- •Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
- •More than one chronic total occlusion (CTO)
结局指标
主要结局
All-cause mortality, myocardial infarction, or urgent revascularization
时间窗: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI
次要结局
- Peri-procedural (TAVI) myocardial infarction(Until the last included patients have been followed for 1 year after the TAVI)
- Target lession revascularization(Until the last included patients have been followed for 1 year after the TAVI)
- Quality of Life(30 days and 1 year)
- Cardiovascular mortality, myocardial infarction, or urgent PCI(Until the last included patients have been followed for 1 year after the TAVI)
- Myocardial infarction(Until the last included patients have been followed for 1 year after the TAVI)
- Urgent revascularization(Until the last included patients have been followed for 1 year after the TAVI)
- Peri-procedural (PCI) myocardial infarction(Until the last included patients have been followed for 1 year after the TAVI)
- Any revascularization(Until the last included patients have been followed for 1 year after the TAVI)
- Stroke or transient ischemic attack (TIA)(Until the last included patients have been followed for 1 year after the TAVI)
- Stent thrombosis(Until the last included patients have been followed for 1 year after the TAVI)
- All cause mortality or myocardial infarction(Until the last included patients have been followed for 1 year after the TAVI)
- Admission for new onset of heart failure(Until the last included patients have been followed for 1 year after the TAVI)
- Acute kidney injury(Until the last included patients have been followed for 1 year after the TAVI)
- Target vessel revascularization(Until the last included patients have been followed for 1 year after the TAVI)
- Cost effectiveness analysis(Until the last included patients have been followed for 1 year after the TAVI)
- All cause mortality(Until the last included patients have been followed for 1 year after the TAVI)
- Cardiovascular mortality(Until the last included patients have been followed for 1 year after the TAVI)
- Cardiovascular mortality or myocardial infarction(Until the last included patients have been followed for 1 year after the TAVI)
- Angina status (Seattle questionnaire), CCS and NYHA class(30 days and 1 year)
- Bleeding(Until the last included patients have been followed for 1 year after the TAVI)
研究者
Thomas Engstrom
Consultant, PhD, DMSci
Rigshospitalet, Denmark
研究点 (14)
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