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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: 248190836@qq.com
• Phone: +86 13294957739

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• RENATUS transcatheter aortic valve for severe aortic stenosis

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• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

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• Navitor TAVI valve in Japanese patients with severe aortic stenosis

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• Improving quality of life for patients with severe aortic stenosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.