CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis (NCT07469371) | Clinical Trial Compass
RecruitingNot Applicable
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
China300 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Willing to participate in the study and able to provide written informed consent.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Major Adverse Cardiovascular Events (MACE)
Timeframe: At 1 year (365 days) post-AVR
Trial details
NCT IDNCT07469371
SponsorYan'an Affiliated Hospital of Kunming Medical University