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 Engstrom12 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
干预措施
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
- 12
- 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)
研究组 & 干预措施
TAVI only
No Intervention
TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
TAVI + FFR-guided complete revascularization
Experimental
TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter .
干预措施: PCI (Procedure)
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)
- 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)
- Cardiovascular mortality, myocardial infarction, or urgent PCI(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)
- 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)
- Quality of Life(30 days and 1 year)
- Cost effectiveness analysis(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 (12)
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