CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis: A Randomized Controlled Trial

What this Trial Is About

Severe aortic stenosis (AS) often occurs alongside coronary artery disease (CAD), complicating treatment decisions before aortic valve replacement (AVR). Researchers are evaluating whether adding a functional heart blood flow test called CT-derived fractional flow reserve (CT-FFR) to the usual coronary computed tomography angiography (CCTA) can better guide treatment and improve patient outcomes. This randomized controlled trial includes 300 patients with severe AS scheduled for transcatheter or surgical AVR to compare these two approaches. Participants are randomly assigned to one of two groups: one group will have their preoperative revascularization decisions guided by both CCTA anatomical information and CT-FFR functional data, while the other group will have decisions based on CCTA alone. The study uses CT-FFR to identify significant ischemia and helps the Heart Team plan revascularization strategies such as PCI or CABG accordingly. Both groups receive standard AVR treatment, and the follow-up period lasts one year after the procedure. During the study, patients undergo preoperative coronary imaging and assessments to guide treatment planning. Researchers will track major adverse cardiovascular events (MACE) over 365 days post-AVR, including heart attacks, unstable angina, cardiac death, strokes, revascularizations, valve interventions, and serious bleeding. Secondary outcomes include mortality and composite endpoints at 30 days and one year. This trial aims to see if combining CT-FFR with CCTA can optimize treatment decisions and reduce post-surgery complications.

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