Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
研究概览
简要总结
The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
详细描述
Prospective, single center, open-label study to
- compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI
- correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI
- correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- •Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
- •Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
- •CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
- •Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)
- •Eligible for coronary CT-angiography and functional assessment (CT-FFR)
排除标准
- •Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
- •Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
- •Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
- •Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
- •Contraindication to adenosine (e.g. bronchial asthma)
- •Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR <30 ml/min)
- •Presence of cardiogenic shock
- •Participation in another interventional study involving the left heart or coronary arteries
结局指标
主要结局
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
时间窗: 6 Months
Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio. The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).
次要结局
- Diagnostic accuracy by considering FFR values of >0.80 as normal(6 Months)
- Diagnostic accuracy by considering RFR values of >0.89 as normal(6 Months)