Precision heart care at the nexus of vascular biology and artificial intelligence.
End-to-end artificial intelligence applied to non-invasive CT scans of the heart arteries, Cleerly® ISCHEMIA™ is a first-of-its-kind, FDA-cleared heart disease evaluation device that integrates novel heart disease features to determine likelihood of coronary artery ischemia in a manner that advances a new paradigm of personalized care.
By applying advanced AI to novel measurements of heart disease, Cleerly ISCHEMIA enables a modern approach to personalized heart disease assessment that doesn’t rely upon population-based assumptions.
We tested and validated the Cleerly ISCHEMIA device in the largest clinical trial to date.
And then it validated again. And again. And again.
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.1-4
Main clinical validation study
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.1
External validation study #1
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 (AUC 0.91), FFRCT (AUC 0.90) and PET (AUC 0.88) performed similarly, outperforming SPECT (AUC 0.71) in predicting ischemia.2
"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 is a binary indication of 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. The Cleerly ISCHEMIA binary output is consistent with that used in professional societal practice guidelines, including the ACC/AHA Chest Pain Guidelines.6
Through 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.1-4
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.”
With any new CPT® Code, there is a need to understand how to apply it to FDA-cleared and commercially available technologies. In this regard, the determination of whether a CPT® code applies to a given technology or service is based solely on the CPT® Code description, and not on the clinical vignettes that describe the technology or service.
Cleerly ISCHEMIA Provides a Non-Invasive Estimate of Coronary Fractional Flow Reserve
Cleerly ISCHEMIA Provides Results Derived from Augmentative Software Analysis of the Data Set from a CCTA
Cleerly ISCHEMIA is Designed for Interpretation and Report by a Physician or Other Qualified Health Care Professional
Cleerly ISCHEMIA is available by prescription only.
Request your N-of-1 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.