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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).