CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis

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: 1. 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). 2. 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.