Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events (MACE) at 12 months
研究概览
简要总结
The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.
详细描述
The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA).
The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent, blinded Clinical Events Committee will adjudicate all primary and key secondary endpoints based on medical records. The committee members will not be informed of the participants' group allocation (PCD-CT vs. ICA). The statistical analysis will also be conducted by an independent statistician blinded to treatment assignment.
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 indication for intervention according to current European Society of Cardiology (ESC) guidelines
- •TAVR candidate
- •Written informed consent
排除标准
- •Cardiogenic shock at presentation (e.g., emergency indication for TAVR)
- •Severe renal impairment with an estimated glomerular filtration rate of <30 mL/min/1.73 m²
- •Life expectancy <1 year due to other severe non-cardiac disease (e.g., malignancy)
- •Pregnancy
研究组 & 干预措施
PCD-CT-Guided Diagnostic Strategy
Participants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery.
干预措施: PCD-CT-Guided Diagnostic Strategy (Diagnostic Test)
Standard Invasive Coronary Angiography
Participants randomized to this arm will undergo routine invasive coronary angiography (ICA) as the standard of care for pre-TAVR assessment of coronary artery disease.
干预措施: Standard Invasive Coronary Angiography (Diagnostic Test)
结局指标
主要结局
Major adverse cardiovascular events (MACE) at 12 months
时间窗: 12 months after randomization
MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding events. All events will be adjudicated by an independent, blinded clinical events committee.
次要结局
- All-cause mortality at 12 months(12 months after randomization)
- Cardiovascular mortality at 12 months(12 months after randomization)
- Nonfatal myocardial infarction at 12 months(12 months after randomization)
- Nonfatal stroke at 12 months(12 months after randomization)
- Urgent revascularization at 12 months(12 months after randomization)
- Bleeding events at 12 months(12 months after randomization)