Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07469371

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

Led by Yan'an Affiliated Hospital of Kunming Medical University · Updated on 2026-04-16

300

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Severe aortic stenosis confirmed by echocardiography with peak aortic jet velocity ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or aortic valve area ≤1.0 cm² (or indexed aortic valve area ≤0.6 cm²/m²)
  • New York Heart Association (NYHA) functional class II or higher
  • Eligible for both transfemoral transcatheter aortic valve replacement and surgical aortic valve replacement
  • Undergoing preoperative coronary computed tomography angiography (CCTA)
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 other active infection
  • Severe vascular disease preventing safe prosthetic valve implantation
  • Ascending aorta diameter ≥50 mm
  • Previous prosthetic valve implantation or prior coronary artery bypass grafting (CABG)
  • Aortic root anatomy unsuitable for transcatheter valve implantation confirmed by imaging
  • Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by echocardiography
  • Acute myocardial infarction within 30 days before surgery
  • Stroke or transient ischemic attack within 3 months before surgery
  • Bleeding or coagulation disorders within 3 months before surgery requiring hospitalization, blood transfusion, or incompatible with antiplatelet therapy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yan'an Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, China, 650050

Actively Recruiting

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Research Team

X

Xirui Duan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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