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

NCT07469371 | Recruiting DMC

• 2 other identifiers: 2025-412-012026Y0391
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  The primary endpoint is a cardiovascular-focused composite including major adverse cardiovascular events (MACE, defined as cardiac death, nonfatal myocardial infarction, unstable angina, heart failure admission, clinically-driven target vessel revascularization, or valve re-intervention). This outcome will be reported as the percentage of participants experiencing at least one of these events.

  At 1 year (365 days) post-AVR

Secondary Outcomes (4)

• Incidence of All-Cause Mortality at 1 Year

  At 1 year (365 days) post-AVR

• Incidence of All-Cause Mortality at 30 Days

  At 30 days post-AVR

• Incidence of Patient-Oriented Composite Endpoint at 1 Year

  At 1 year (365 days) post-AVR

• Incidence of Patient-Oriented Composite Endpoint at 30 Days

  At 30 days post-AVR

Other Outcomes (1)

• Exploratory Outcome: Rate of Concomitant or Staged Coronary Revascularization

  Up to 30 days prior to AVR and at the time of the AVR procedure

Study Arms (2)

CCTA + CT-FFR Group

EXPERIMENTAL

Preoperative revascularization decision-making (TAVR/SAVR) is guided by both CCTA anatomical information and CT-FFR functional information.

Other: CCTA plus CT-FFR-informed preoperative decision strategy

CCTA Group

ACTIVE COMPARATOR

Preoperative revascularization decision-making (TAVR/SAVR) is guided solely by CCTA anatomical information.

Other: CCTA-guided preoperative decision strategy

Interventions

CCTA plus CT-FFR-informed preoperative decision strategy OTHER

Preoperative coronary evaluation and revascularization decision-making before aortic valve replacement are based on combined CCTA anatomical assessment and CT-FFR functional assessment. When anatomical and functional assessments are concordant, both are considered in treatment planning. When anatomical and functional assessments are discordant, the CT-FFR functional result serves as the primary basis for revascularization decision-making.

CCTA + CT-FFR Group

CCTA-guided preoperative decision strategy OTHER

CCTA is performed as the standardized preoperative anatomic coronary assessment in patients with severe aortic stenosis scheduled for aortic valve replacement. Coronary stenosis is evaluated by 2 experienced radiologists using the 18-segment coronary model, visual diameter stenosis assessment, and CAD-RADS 2.0 classification. In the control strategy, coronary evaluation and revascularization planning are based on CCTA anatomic findings alone.

CCTA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Undergoing preoperative coronary computed tomography angiography (CCTA).
• Willing to participate in the study and able to provide written informed consent.

You may not qualify if:

• 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).
• Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation.
• Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography.
• Acute myocardial infarction within 30 days before surgery.
• Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery.
• 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.

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Yan'an Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, 650050, China

RECRUITING

Related Publications (3)

• Cury RC, Leipsic J, Abbara S, Achenbach S, Berman D, Bittencourt M, Budoff M, Chinnaiyan K, Choi AD, Ghoshhajra B, Jacobs J, Koweek L, Lesser J, Maroules C, Rubin GD, Rybicki FJ, Shaw LJ, Williams MC, Williamson E, White CS, Villines TC, Blankstein R. CAD-RADS 2.0 - 2022 Coronary Artery Disease - Reporting and Data System.: An expert consensus document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR) and the North America Society of Cardiovascular Imaging (NASCI). J Am Coll Radiol. 2022 Nov;19(11):1185-1212. doi: 10.1016/j.jacr.2022.09.012.

  PMID: 36436841 BACKGROUND

• Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):450-500. doi: 10.1016/j.jacc.2020.11.035. Epub 2020 Dec 17.

  PMID: 33342587 BACKGROUND

• Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.

  PMID: 40878295 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Chengde Liao

  Yan'an Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xirui Duan

CONTACT

+86 13294957739; 248190836@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment allocation. Participants and treating clinicians will not be blinded because CT-FFR results are used for preoperative decision-making in the intervention arm. Unblinding will occur after completion of 1-year follow-up and database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with severe aortic stenosis scheduled for aortic valve replacement will be randomized 1:1 to a CCTA+CT-FFR-guided preoperative decision strategy or a CCTA-only preoperative decision strategy and followed for 365 days.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (1)