Cleerly® ISCHEMIA™ Solution for Heart Disease Analysis — FDA cleared, evidence-based AI and machine learning-based algorithm detects heart disease-associated ischemia. Read the full release.

Ischemia.
Reinvented.

Precision heart care at the nexus of vascular biology and artificial intelligence.

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Cleerly ISCHEMIA is a first-of-its-kind, FDA-cleared heart disease evaluation that uses 37 measures of heart health to determine likelihood of coronary artery ischemia at a per-vessel level. Cleerly ISCHEMIA uses machine learning and concise reporting to aid physicians in personalizing patient treatment, including the planning of interventional treatments such as stent placement.

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Informed Decision Making.

When used in conjunction with Cleerly LABS, Cleerly ISCHEMIA findings impacted and changed physician decision making in a majority of patients.6

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Personalized Assessment.

By applying advanced AI to novel measurements of heart disease, Cleerly ISCHEMIA enables a modern approach to personalized heart disease assessment.

 

Clinical Validation

Cleerly ISCHEMIA’s ability to determine a likely invasive FFR was validated through multiple clinical trials with invasive FFR as the gold standard. Cleerly ISCHEMIA performed consistently well across all studies, having either outperformed or equivalent to other noninvasive measures of ischemia — specifically FFRCT, myocardial perfusion imaging (SPECT), and PET.1–5
 

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CREDENCE Trial

In the prospective, multicenter CREDENCE trial, Cleerly ISCHEMIA demonstrated higher diagnostic accuracy and area under the curve compared to FFRCT and stress testing, as referenced to 868 invasive measurements by fractional flow reserve (FFR), the ‘gold standard’ for determining ischemia.2

Cleerly ISCHEMIA - Clinical Validation, CREDENCE trial

PACIFIC Trial

In a post-hoc analysis of the PACIFIC study, Cleerly ISCHEMIA was compared to FFRCT, 15O-H2O PET and SPECT to predict invasive FFR≤0.8 as reference standard. On a per-patient basis Cleerly ISCHEMIA, FFRCT and PET performed similarly and outperformed SPECT in predicting ischemia.2 Cleerly ISCHEMIA, using multivariate analysis, was the only non-invasive ischemia test that was prognostic of future MACE events, FFRCT and SPECT were not.2

Cleerly ISCHEMIA - Clinical validation, PACIFIC trial AUC and Accuracy chart

Cleerly ISCHEMIA - Clinical validation, PACIFIC trial Prognostic Utility chart

"The Cleerly method for looking at the CTA provides more information than almost any of the other CTAs do. And with that, we're able to look at different aspects of the vessel that would change the way we would treat it. And I think this makes the Cleerly product a potential game changer."

Morton J. Kern, MD, MSCAI, FACC, FAHA
Interventional Cardiologist Professor of Medicine, University of California, Irvine

 

How Cleerly ISCHEMIA Works

A Cleerly ISCHEMIA Index (CII) is provided for all analyzable coronary vessels as a part of the Cleerly analysis. The CII indicates ischemia either being unlikely present or likely present based on the threshold equivalent to invasive fractional flow reserve (FFR) measures of >0.80 vs. ≤0.80, respectively. By integrating coronary atherosclerosis and vascular morphology characteristics into a single physiologic measure that identifies likely coronary ischemia, the Cleerly ISCHEMIA analysis provides actionable information to the physician to assess a patient's heart health.1–5

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Clinical Workflow

 

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Applying the Category I CPT® Code 75580 to Cleerly ISCHEMIA

Category 1 CPT® Code 75580: “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.”

Cleerly ISCHEMIA is a novel, artificial intelligence-enabled method applied to typically acquired CCTA to determine ranges of FFR values that categorize a vessel’s likelihood of exhibiting ischemia. A physician or other qualified healthcare professional then assesses the data on a vessel by vessel level to determine what, if any, intervention is needed. The ability for Cleerly ISCHEMIA to provide this comprehensive lesion-by-lesion mapping within a vessel for the the clinically actionable features of coronary artery disease can be used to support the care team in determining whether there may be a lesion to be considered for coronary revascularization and if so, to guide the care team to such relevant factors as ischemia, stenosis and atherosclerosis.

Cleerly ISCHEMIA is billable under the CAT 1 CPT® Code 75580, as it meets the guidelines determined by the American Medical Association.

Cleerly ISCHEMIA is available by prescription only.

 

Request your Cleerly ISCHEMIA Demo

Contact us for a one-on-one software demonstration with a Cleerly expert to see how bringing Cleerly’s AI‑driven CCTA analysis to your organization can empower you to provide personalized treatment decisions for your patients.

Cleerly® ISCHEMIA™ analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly® LABS™ software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis. Rx Only.