Personalized, Precise, Measurable
Plaque, stenosis, and ischemia — all in one AI-enabled CCTA solution
Today’s symptom-focused approach to cardiovascular care is flawed – but we have the tools to change it.
How Cleerly Transforms Cardiac Risk Assessment
Cleerly’s AI algorithms rapidly interpret coronary computed tomography angiography (CCTA) scans to generate a 3D model of the coronary arteries, locate and quantify stenoses, as well as identify, quantify and categorize types of plaque.
When CCTA with Cleerly is included as an element of a physician’s workflow, it can be a powerful diagnostic aid that can reveal the degree of atherosclerosis, stenosis, and likelihood of ischemia, as well as provide clear measurements of changes in disease.
Cleerly is Diagnostically Accurate
Multicenter and single-center clinical trials have consistently demonstrated Cleerly’s robust clinical utility, including higher diagnostic accuracy, over tests such as nuclear SPECT stress testing.1-7
In a post-hoc analysis of the independent PACIFIC study, Cleerly ISCHEMIA demonstrated higher diagnostic accuracy compared with SPECT and similar accuracy to PET in the prediction of ischemia.1
Compared to CCTA alone, Cleerly reduces the overestimation of stenosis seen commonly with clinical readers.7-8

Cleerly Informs Action
In the CERTAIN trial, compared to conventional CCTA interpretation alone, the use of Cleerly’s products led to significant changes in clinical decision-making and patient management in more than 57% of patients, and increased physicians’ diagnostic confidence five-fold compared to a standard assessment of CCTA.9
Use of Cleerly also resulted in a 39% change in the degree of coronary stenosis, a 37% reduction in the need for further invasive and non-invasive testing, and a 28% increase in the use of preventive medications.9

Cleerly is Confirmed
In 2021, the American College of Cardiology (ACC), American Heart Association (AHA), and other groups, identified CCTA as a Class 1 recommendation, with level A of evidence, in the evaluation of patients with stable and acute chest pain who have no known coronary artery disease (CAD).10
Cleerly analyses are clinically validated,1-9 and can be billed using CPT® Code 75580 for Cleerly ISCHEMIA, as well as codes 0623T, 0624T, 0625T, 0626T for reporting Cleerly’s advanced coronary atherosclerosis analysis.


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Interested in integrating Cleerly ISCHEMIA and plaque analyses into your practice?
Request a time for your personalized demo of the software and learn how we can complement your care approach.
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Cleerly ISCHEMIA Clinical Evidence
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Heart disease is still the leading cause of death in the United States. We've obviously been missing something. If we can see it early and affect change, then it will save lives. That's why Cleerly is a game changer.
Cleerly FAQs
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What is Cleerly?
The Cleerly analysis assesses the presence, amount, and type of plaque in the heart’s arteries using coronary computed tomography angiography (CCTA). Cleerly’s artificial intelligence-driven algorithms analyze and transform images captured from the CCTA into detailed measurements and reports for review. The results of the Cleerly analysis offer a clear understanding of the amount and types of plaque in the arteries. Cleerly can also detect stenosis and likelihood of ischemia. Providers can use this information to assess a patient's risk for a heart attack and offer personalized treatment recommendations.
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How has Cleerly been clinically proven?
Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period. Multi-center trials confirm Cleerly’s accuracy in identifying, quantifying, and characterizing CAD.11-17
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Is Cleerly reimbursable?
Cleerly ISCHEMIA can be billed using CPT® Code 75580 which is a category I CPT® code for the noninvasive estimate of coronary fractional flow reserve derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified healthcare professional.
Several Category III CPT® codes (CPT® 0623T, 0624T, 0625T, 0626T) can be used for reporting Cleerly’s advanced coronary atherosclerosis analysis.
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How does CCTA with Cleerly compare to conventional heart disease tests?
Cleerly's model of personalized cardiovascular care leverages our AI-enabled analysis of coronary computed tomography angiography (CCTA) images to identify, characterize, and quantify plaque buildup.
Cleerly + CCTA Comparison to Current Gold Standards
Methodology Limitations Cleerly Advantage Level III Expert Readers Physicians frequently overcall stenosis and are also in high demand Cleerly has high agreement with the most highly trained (Level 3) expert readers, and can reduce the overcall of stenoses11 Invasive Quantitative Coronary Angiography (QCA)12 Less than 38% of patients who undergo catheterization actually have obstructive coronary artery disease18 Cleerly’s outputs are closely aligned with coronary angiography12 and use of Cleerly can accurately reduce the number of patients referred for invasive angiography as compared to other clinical means17 Nuclear Myocardial Perfusion Imaging (MPI) Nuclear stress tests detect ischemia but say nothing about the type or burden of plaque
90% of stress tests come back with normal results, and MPI studies have high rates of false positive and false negative results14
Compared to MPI, Cleerly reduces overestimation of CAD severity (false positives) that trigger unnecessary referral to ICA and can save over 30% per patient as compared to a standard MPI based triage to invasive angiography14 Intravascular Ultrasound (IVUS) IVUS accurately estimates lumen stenosis and coronary plaque burden but is expensive and invasive, performed only in the cath lab Cleerly demonstrates high correlation with IVUS for lumen stenosis and measures of plaque size and burden16-19 Near Field Infrared Spectrometry (NIRS) Provides quantitative measure of lipid burden and is validated for detection of lipid core plaque – but is offered in combination with IVUS and requires catheterization16 Cleerly demonstrates high correlation with NIRS for measures of low density plaque16 CCTA CCTA (without Cleerly) is likely better than MPI alone in terms of both sensitivity (95% vs. 74%) and specificity (63% vs. 43%) for detecting stenosis greater than 50%14. Close agreement to QCA and FFR evaluation – but with results available in less than 15 minutes and no need for invasive catheterization Compared to CCTA alone, Cleerly reduces the overestimation of stenosis seen commonly with clinical readers CCTA + Cleerly approach may allow for a reduction of up to 95% in the need for invasive catheterization in stable patients with suspected CAD17 -
Can Cleerly’s software track disease progression?
Physicians can use Cleerly’s COMPARE tool to evaluate multiple CCTA exams from the same patient. This allows for a comparison of scans taken at different times, which can reveal progression or changes in plaque state.
Request a Demo
Interested in integrating Cleerly ISCHEMIA and plaque analyses into your practice? Request a time for your personalized demo of the software and learn how we can complement your care approach.
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References
1 Nurmohamed NS, Danad I, Jukema RA, et al.; CREDENCE and PACIFIC-1 Investigators. Development and Validation of a Quantitative Coronary CT Angiography Model for Diagnosis of Vessel-Specific Coronary Ischemia. JACC Cardiovasc Imaging. 2024 Mar 13:S1936-878X(24)00039-1.
2 Andrew Chiou, Melody Hermel, Rajbir Sidhu, et al. AI-QCT, CT-FFR, and physician visual interpretation in the per-vessel prediction of abnormal invasive adenosine FFR, European Heart Journal - Imaging Methods and Practice, 2024.
3 Karlsberg RP, Gonzalez Quesada C, Samuels B et al. High diagnostic accuracy of a novel artificial intelligence guided quantitative coronary computed tomography algorithm for predicting myocardial ischemia. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S28–S29 Published in issue: July, 2023
4 Lipkin I, Telluri A, Kim Y et al. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol. 2022 Sep;219(3):407-419.
5 Bär S, Nabeta T, Maaniitty T, et al. Prognostic Value of a Novel Artificial Intelligence-Based Coronary Computed Tomography Angiography-Derived Ischemia Algorithm for Patients with Suspected Coronary Artery Disease. Eur Heart J Cardiovasc Imaging. 2023 Dec 12:jead339.
6 Nurmohamed N, Cole J, Budoff M et al. Impact of Atherosclerosis Imaging-Quantitative Computed Tomography on Diagnostic Certainty, Downstream Testing, Coronary Revascularization and Medical Therapy: The CERTAIN Study. Eur Heart J Cardiovasc Imaging. 2024 Jan 25:jeae029. This study was sponsored by Cleerly, Inc. and journal article authors Udo Hoffman, M.D., James Min, M.D. and James Earls, M.D. are employees of Cleerly, Inc.
7 Kim Y, Choi AD, Telluri A, et al. Atherosclerosis Imaging Quantitative Computed Tomography (AI-QCT) to guide referral to invasive coronary angiography in the randomized controlled CONSERVE trial. Clin Cardiol. 2023 May;46(5):477-483. doi: 10.1002/clc.23995. Epub 2023 Feb 27.
8 Griffin WF, Choi AD, Riess JS, et al. AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy. JACC Cardiovasc Imaging. 2023 Feb;16(2):193-205. doi: 10.1016/j.jcmg.2021.10.020.
9 Nurmohamed NS, Cole JH, Budoff M et al. Impact of Atherosclerosis Imaging-Quantitative Computed Tomography on Diagnostic Certainty, Downstream Testing, Coronary Revascularization and Medical Therapy: The CERTAIN Study. Eur Heart J Cardiovasc Imaging. 2024 Jan 25:jeae029. doi: 10.1093/ehjci/jeae029. Epub ahead of print. PMID: 38270472.
10 Writing Committee Members; Gulati M, Levy PD, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Nov 30;78(22):e187-e285. doi: 10.1016/j.jacc.2021.07.053.
11 Choi AD, Marques H, Kumar V, et al. CT Evaluation by Artificial Intelligence for Atherosclerosis, Stenosis and Vascular Morphology (CLARIFY): A Multi-center, international study. J Cardiovasc Comput Tomogr. 2021 Nov-Dec;15(6):470-476. doi: 10.1016/j.jcct.2021.05.004. Epub 2021 Jun 12. PMID: 34127407.
12 Griffin WF, Choi AD, Riess JS, Met al. AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy. JACC Cardiovasc Imaging. 2023 Feb;16(2):193-205. doi: 10.1016/j.jcmg.2021.10.020. Epub 2022 Feb 16. PMID: 35183478.
13 Jonas RA, Barkovich E, Choi AD, et al The effect of scan and patient parameters on the diagnostic performance of AI for detecting coronary stenosis on coronary CT angiography. Clin Imaging. 2022 Apr;84:149-158. doi: 10.1016/j.clinimag.2022.01.016. Epub 2022 Feb 3. PMID: 35217284.
14 Lipkin I, Telluri A, Kim Y, et al/. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol. 2022 Sep;219(3):407-419. doi: 10.2214/AJR.21.27289. Epub 2022 Apr 20. PMID: 35441530.
15 Cardoso R, Choi AD, Shiyovich A, et al How early can atherosclerosis be detected by coronary CT angiography? Insights from quantitative CT analysis of serial scans in the PARADIGM trial. J Cardiovasc Comput Tomogr. 2023 Nov-Dec;17(6):407-412. doi: 10.1016/j.jcct.2023.08.012. Epub 2023 Oct 3. PMID: 37798157.
16 Omori H, Matsuo H, Fujimoto S, et al. Determination of lipid-rich plaques by artificial intelligence-enabled quantitative computed tomography using near-infrared spectroscopy as reference. Atherosclerosis. 2023 Dec;386:117363. doi: 10.1016/j.atherosclerosis.2023.117363. Epub 2023 Oct 29. PMID: 37944269.
17 Kim Y, Choi AD, Telluri A, et al. Atherosclerosis Imaging Quantitative Computed Tomography (AI-QCT) to guide referral to invasive coronary angiography in the randomized controlled CONSERVE trial. Clin Cardiol. 2023 May;46(5):477-483. doi: 10.1002/clc.23995. Epub 2023 Feb 27.
18 Patel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272. Erratum in: N Engl J Med. 2010 Jul 29;363(5):498. PMID: 20220183; PMCID: PMC3920593.
19 Hakim D, Coskun AU, Maynard C. Endothelial shear stress computed from coronary computed tomography angiography: A direct comparison to intravascular ultrasound. J Cardiovasc Comput Tomogr. 2023 May-Jun;17(3):201-210. doi: 10.1016/j.jcct.2023.03.009.