Severe Aortic StenosisCLEAR-ASNCT07469371
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
A study testing CCTA plus CT-FFR-informed preoperative decision strategy and CCTA-guided preoperative decision strategy in people with Severe Aortic Stenosis, run by Yan'an Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- CCTA plus CT-FFR-informed preoperative decision strategy and CCTA-guided preoperative decision strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yan'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan, 650050
Xirui Duan, +86 13294957739, 248190836@qq.com
Chengde Liao, +86 13888040671, chengdeliao@qq.com
About this study
Official title: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis: A Randomized Controlled Trial
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.
Read the detailed description
Patients with severe aortic stenosis (AS) frequently have concomitant coronary artery disease (CAD), which complicates pre-operative evaluation and clinical decision-making for transcatheter (TAVR) or surgical aortic valve replacement (SAVR). Although coronary computed tomography angiography (CCTA) provides excellent anatomical evaluation and has become a standard pre-AVR workflow, it is insufficient for determining the functional and hemodynamic significance of coronary lesions. CT-derived fractional flow reserve (CT-FFR) offers a novel, non-invasive method to evaluate the ischemic burden.
The objective of this prospective, single-center, randomized, parallel-controlled trial is to determine whether a "functional + anatomical" assessment strategy using CT-FFR provides incremental value over an "anatomical-only" strategy.
A total of 300 eligible patients with severe AS planned for AVR will be randomized in a 1:1 ratio into two groups:
- Experimental Group (CCTA + CT-FFR): The Heart Team will formulate the revascularization strategy (e.g., concomitant or staged PCI/CABG) based on both CCTA anatomical stenosis and CT-FFR physiological data (using a threshold of CT-FFR ≤0.80 to define hemodynamically significant ischemia).
- Active Comparator Group (CCTA alone): The Heart Team will formulate the revascularization strategy based solely on CCTA anatomical grading according to the CAD-RADS classification.
All participants will be followed for 365 days post-AVR. The primary endpoint is a patient-oriented composite of major adverse cardiovascular events (MACE, including nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding. The study hypothesizes that incorporating CT-FFR into routine pre-AVR evaluation will optimize concomitant revascularization decisions, avoid unnecessary invasive procedures, and ultimately reduce the risk of post-operative adverse events.
- Conditions
- Severe Aortic Stenosis
- Being tested
- CCTA plus CT-FFR-informed preoperative decision strategy, CCTA-guided preoperative decision strategy
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA plus CT-FFR-informed preoperative decision strategyOther
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-guided preoperative decision strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CCTA + CT-FFR Group | Experimental | Preoperative revascularization decision-making (TAVR/SAVR) is guided by both CCTA anatomical information and CT-FFR functional information. Receives: 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. Receives: Other: CCTA-guided preoperative decision strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year (365 days) post-AVR
Secondary outcomes (4)
Incidence of All-Cause Mortality at 1 Year
The rate of death from any cause, including both cardiac and non-cardiac deaths. Reported as the percentage of participants.
Measured: At 1 year (365 days) post-AVR
Incidence of All-Cause Mortality at 30 Days
The rate of early death from any cause (cardiac and non-cardiac). Reported as the percentage of participants.
Measured: At 30 days post-AVR
Incidence of Patient-Oriented Composite Endpoint at 1 Year
The composite of MACE (nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding occurring within the early post-operative period.
Measured: At 1 year (365 days) post-AVR
Incidence of Patient-Oriented Composite Endpoint at 30 Days
The composite of MACE (nonfatal myocardial infarction, unstable angina, cardiac death, or heart failure admission), disabling stroke, clinically-driven target vessel revascularization, valve re-intervention, and life-threatening or disabling bleeding occurring within the early post-operative period .
Measured: At 30 days post-AVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengde Liao, Principal investigator, Yan'an Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469371
- Sponsor's protocol ID
- 2025-412-01
- Other IDs
- 2026Y0391
- Acronym
- CLEAR-AS
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing has not yet been determined. The study team will decide after completion of the trial, database lock, and review of applicable ethical, privacy, and institutional requirements.
Publications
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.
PubMed 36436841Writing 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.
PubMed 33342587Praz 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.
PubMed 40878295