CT-FFR-guided revascularization for people with severe aortic stenosis

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

This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yan'an Affiliated Hospital of Kunming Medical University (Academic / other)
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT07469371 on ClinicalTrials.gov

What this trial studies

Severe aortic stenosis patients frequently have coexisting coronary artery disease, and preoperative coronary CT angiography (CCTA) provides anatomy but not physiological ischemia data. This prospective, single-center, randomized controlled trial will enroll 300 patients scheduled for transcatheter or surgical aortic valve replacement and randomize them 1:1 to revascularization decisions guided by CCTA plus CT-FFR versus CCTA alone. The CT-FFR arm will use a CT-FFR threshold of ≤0.80 to define hemodynamically significant lesions and the Heart Team will plan PCI or CABG accordingly. All participants will be followed for 365 days to compare major adverse cardiovascular events and other clinical outcomes.

Who should consider this trial

Good fit: Adults over 18 with echocardiographically confirmed severe aortic stenosis (e.g., Vmax ≥4.0 m/s, mean gradient ≥40 mmHg, or AVA ≤1.0 cm²), NYHA class II or higher, who are candidates for TAVR or SAVR, scheduled for preoperative CCTA, and able to provide informed consent.

Not a fit: Patients with allergy to iodinated contrast, contraindications to antiplatelet/anticoagulant therapy, active infection such as endocarditis, severe vascular disease precluding safe implantation, or those not eligible for AVR are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding CT-FFR could help avoid unnecessary coronary procedures and improve cardiovascular outcomes after valve replacement.

How similar studies have performed: CT-FFR has been validated in general coronary artery disease populations for identifying ischemia and guiding revascularization, but its specific benefit in severe aortic stenosis patients undergoing AVR has limited prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Age \>18 years.
2. 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 \[or indexed aortic valve area (AVAi) ≤0.6 cm²/m²\].
3. New York Heart Association (NYHA) functional class II or higher.
4. Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
5. Undergoing preoperative coronary computed tomography angiography (CCTA).
6. Willing to participate in the study and able to provide written informed consent.

Exclusion Criteria:

1. Allergy to prosthetic valve materials or iodinated contrast agents.
2. Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy.
3. Active infective endocarditis or any other active infection.
4. Severe vascular disease precluding safe implantation of a prosthetic valve.
5. Ascending aortic diameter ≥50 mm.
6. Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG).
7. Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation.
8. Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography.
9. Acute myocardial infarction within 30 days before surgery.
10. Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery.
11. 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.

Where this trial is running

Kunming, Yunnan

• Yan'an Hospital Affiliated to Kunming Medical University — Kunming, Yunnan, China (Recruiting)

Study contacts

• Principal investigator: Chengde Liao — Yan'an Affiliated Hospital of Kunming Medical University
• Study coordinator: Xirui Duan

Conditions Severe Aortic Stenosis