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| ID | Type | Description | Link |
|---|---|---|---|
| 2026Y0391 | Other Grant/Funding Number | Department of Education of Yunnan Province |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA + CT-FFR Group | Experimental | Preoperative revascularization decision-making (TAVR/SAVR) is guided by both CCTA anatomical information and CT-FFR functional information. |
|
| CCTA Group | Active Comparator | Preoperative revascularization decision-making (TAVR/SAVR) is guided solely by CCTA anatomical information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1 year (365 days) post-AVR |
| Incidence of All-Cause Mortality at 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome: Rate of Concomitant or Staged Coronary Revascularization | An exploratory procedural endpoint defined as the proportion of patients who undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) concomitantly at the time of aortic valve replacement (AVR), and/or staged PCI/CABG performed within 30 days prior to AVR. This endpoint is included to capture the clinical decision-making pathway and the real-world impact of the preoperative assessment strategy. Reported as the percentage of participants. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xirui Duan | Contact | +86 13294957739 | 248190836@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chengde Liao | Yan'an Affiliated Hospital of Kunming Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yan'an Hospital Affiliated to Kunming Medical University | Recruiting | Kunming | Yunnan | 650050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36436841 | Background | 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. | |
| 33342587 |
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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.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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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.
|
| 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. |
|
The rate of early death from any cause (cardiac and non-cardiac). Reported as the percentage of participants.
| 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. | 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 . | At 30 days post-AVR |
| Up to 30 days prior to AVR and at the time of the AVR procedure |
| 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. |
| 40878295 | 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. |
| D014694 |
| Ventricular Outflow Obstruction |