CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it lacks physiological assessment of myocardial ischemia.
This prospective, single-center, randomized controlled trial aims to evaluate whether integrating functional assessment using CT-derived fractional flow reserve (CT-FFR) with CCTA can optimize revascularization decision-making and improve clinical outcomes. A total of 300 severe AS patients scheduled for transcatheter or surgical AVR will be randomly assigned to either the experimental group (revascularization decisions guided by both CCTA and CT-FFR) or the control group (decisions guided by CCTA alone). Participants will be followed up for 1 year to assess major adverse cardiovascular events and other clinical outcomes.
详细描述
Patients with severe aortic stenosis (AS) frequently have concomitant coronary artery disease (CAD), which complicates pre-operative evaluation and clinical decision-making for transcatheter (TAVR) or surgical aortic valve replacement (SAVR). Although coronary computed tomography angiography (CCTA) provides excellent anatomical evaluation and has become a standard pre-AVR workflow, it is insufficient for determining the functional and hemodynamic significance of coronary lesions. CT-derived fractional flow reserve (CT-FFR) offers a novel, non-invasive method to evaluate the ischemic burden.
The objective of this prospective, single-center, randomized, parallel-controlled trial is to determine whether a "functional + anatomical" assessment strategy using CT-FFR provides incremental value over an "anatomical-only" strategy.
A total of 300 eligible patients with severe AS planned for AVR will be randomized in a 1:1 ratio into two groups:
- Experimental Group (CCTA + CT-FFR): The Heart Team will formulate the revascularization strategy (e.g., concomitant or staged PCI/CABG) based on both CCTA anatomical stenosis and CT-FFR physiological data (using a threshold of CT-FFR ≤0.80 to define hemodynamically significant ischemia).
- Active Comparator Group (CCTA alone): The Heart Team will formulate the revascularization strategy based solely on CCTA anatomical grading according to the CAD-RADS classification.
All participants will be followed for 365 days post-AVR. The primary endpoint is a patient-oriented composite of major adverse cardiovascular events (MACE, including nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding. The study hypothesizes that incorporating CT-FFR into routine pre-AVR evaluation will optimize concomitant revascularization decisions, avoid unnecessary invasive procedures, and ultimately reduce the risk of post-operative adverse events.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to treatment allocation. Participants and treating clinicians will not be blinded because CT-FFR results are used for preoperative decision-making in the intervention arm. Unblinding will occur after completion of 1-year follow-up and database lock.
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 stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm² [or indexed aortic valve area (AVAi) ≤0.6 cm²/m²].
- •New York Heart Association (NYHA) functional class II or higher.
- •Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
- •Undergoing preoperative coronary computed tomography angiography (CCTA).
- •Willing to participate in the study and able to provide written informed consent.
排除标准
- •Allergy to prosthetic valve materials or iodinated contrast agents.
- •Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy.
- •Active infective endocarditis or any other active infection.
- •Severe vascular disease precluding safe implantation of a prosthetic valve.
- •Ascending aortic diameter ≥50 mm.
- •Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG).
- •Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation.
- •Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography.
- •Acute myocardial infarction within 30 days before surgery.
- •Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery.
- •Bleeding or coagulation disorders within 3 months before surgery that required hospitalization or blood transfusion or were otherwise clinically significant and would preclude the antiplatelet therapy required in this study.
研究组 & 干预措施
CCTA + CT-FFR Group
Preoperative revascularization decision-making (TAVR/SAVR) is guided by both CCTA anatomical information and CT-FFR functional information.
干预措施: CCTA plus CT-FFR-informed preoperative decision strategy (Other)
CCTA Group
Preoperative revascularization decision-making (TAVR/SAVR) is guided solely by CCTA anatomical information.
干预措施: CCTA-guided preoperative decision strategy (Other)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: At 1 year (365 days) post-AVR
The primary endpoint is a cardiovascular-focused composite including major adverse cardiovascular events (MACE, defined as cardiac death, nonfatal myocardial infarction, unstable angina, heart failure admission, clinically-driven target vessel revascularization, or valve re-intervention). This outcome will be reported as the percentage of participants experiencing at least one of these events.
次要结局
- Incidence of All-Cause Mortality at 1 Year(At 1 year (365 days) post-AVR)
- Incidence of All-Cause Mortality at 30 Days(At 30 days post-AVR)
- Incidence of Patient-Oriented Composite Endpoint at 1 Year(At 1 year (365 days) post-AVR)
- Incidence of Patient-Oriented Composite Endpoint at 30 Days(At 30 days post-AVR)