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Completed

NCT Number: NCT04828590

The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck, Innsbruck, Austria

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About this study

Coronary artery disease (CAD) is the most common type of heart disease, and it is the leading cause of death worldwide in both men and women. CAD happens when the coronary arteries become hardened and narrowed, which is due to the buildup of cholesterol-containing deposits-plaque on the inner vessel wall. As the plaque grows, less blood can flow through the arteries due to the vessel narrowing. Decreased blood flow can then lead to chest pain (angina), shortness of breath, or even a heart attack.

Fractional flow reserve (FFR), a measure of blood flow reduction caused by vessel narrowing, is accepted as gold standard for assessing the functional significance of stenotic lesions. Multiple randomized trials have demonstrated that FFR has excellent diagnostic value in identifying functionally significant lesions and guiding coronary revascularization procedures. However, FFR is measured invasively through a pressure wire-based cardiac catheter procedure in the catheterization lab. Current guidelines recommend assessing myocardial ischemia of stable patients with CAD through non-invasive functional testing before considering invasive coronary angiography (ICA) or conducting myocardial revascularization.

DEEPVESSEL FFR (DVFFR) is a software medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography -derived FFR values from coronary CT angiogram (CTA) images. It uses deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries and learn complex mapping between FFR values and the encoded information. The quantitative FFR analysis based on the coronary CTA images can help clinicians assess the physiological function in patients with CAD non-invasively.

The primary objective of this study is to evaluate the diagnostic performance of DVFFR software in identifying patients with significant obstructive CAD causing myocardial ischemia, using invasively measured ICA FFR as the reference standard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients' age ≥18 years;
  • Has coronary CTA images acquired by ≥64 multidetector row CT scanner, no earlier than 2016 and within 60 days of the ICA-FFR procedure;
  • Coronary CTA image shows at least one vessel segment (≥2mm diameter) with a diameter stenosis of 30%-90%;

Exclusion criteria

Patients with any of the following conditions at the time of CTA imaging:

  • Acute myocardial infarction;
  • Unstable angina;
  • Pulmonary edema;
  • Heart function classification level III and IV (NYHA heart function classification);
  • Implantable cardioverter defibrillator (ICD);
  • Prior percutaneous coronary intervention (PCI) or pacemaker surgery;
  • Prior coronary artery bypass grafting (CABG) surgery;
  • Prior heart valve replacement;
  • Prior history of complex congenital heart disease;
  • Prior history of cardiomyopathy;
  • BMI >35;
  • Coronary total occlusion.

Treatment and study plan

No intervention

Other

Due to observational study

Primary outcomes

  1. Sensitivity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.

    Time frame: through study completion, an average of 1 year

    On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.

  2. Specificity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.

    Time frame: through study completion, an average of 1 year

    On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.

Secondary outcomes

  1. Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level

    Time frame: through study completion, an average of 1 year

    On the vessel lever, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.

  2. Diagnostic performance including sensitivity, specificity, accuracy, PPV and NPV of DVFFR at the patient level

    Time frame: through study completion, an average of 1 year

    At the patient level, if a patient has at least one vessel that has been identified as causing ischemia, this patient is considered a patient positive for ischemia. A true positive on the patient level is defined as when a patient has at least one lesion with a DVFFR value ≤0.80 and its corresponding reference ICA-FFR is also ≤0.80.

  3. Per-vessel Pearson correlation coefficient between DVFFR and ICA-FFR values

    Time frame: through study completion, an average of 1 year

    Correlation between CT-derived DVFFR values and wire-measured ICA-FFR values will be evaluated at the vessel level.

  4. Diagnostic performance (including sensitivity, specificity, accuracy, PPV and NPV) in detecting hemodynamically significant coronary obstruction using DVFFR and coronary CTA alone, on both vessel level and patient level.

    Time frame: through study completion, an average of 1 year

    For coronary CTA, hemodynamically significant obstruction of a coronary artery is defined as a stenosis ≥50%. The per-patient stenosis degree will be specified as the most severe stenosis among the major epicardial artery vessels presented in coronary CTA.

  5. Stratified analyses on different subgroups of subjects' data

    Time frame: through study completion, an average of 1 year

    Stratified analyses on different subgroups of subjects' data, ranging from patient demographics and disease conditions.

Sponsors and collaborators

Lead sponsor

Keya Medical

Industry

Collaborators

  • Medical University of South Carolina

Registry information

Official study title

Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

Acronym: ADAPT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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