RecruitingNot ApplicableNCT07469371

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

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

Sponsor

Yan'an Affiliated Hospital of Kunming Medical University

Enrollment

300 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Severe aortic stenosis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria11

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERCCTA plus CT-FFR-informed preoperative decision strategy

Preoperative coronary evaluation and revascularization decision-making before aortic valve replacement are based on combined CCTA anatomical assessment and CT-FFR functional assessment. When anatomical and functional assessments are concordant, both are considered in treatment planning. When anatomical and functional assessments are discordant, the CT-FFR functional result serves as the primary basis for revascularization decision-making.

OTHERCCTA-guided preoperative decision strategy

CCTA is performed as the standardized preoperative anatomic coronary assessment in patients with severe aortic stenosis scheduled for aortic valve replacement. Coronary stenosis is evaluated by 2 experienced radiologists using the 18-segment coronary model, visual diameter stenosis assessment, and CAD-RADS 2.0 classification. In the control strategy, coronary evaluation and revascularization planning are based on CCTA anatomic findings alone.