Clinical trial NCT04828590: The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
Official title: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Lead sponsor: Keya Medical
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2021-04-02
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients' age ≥18 years;
2. Has coronary CTA images acquired by ≥64 multidetector row CT scanner, no earlier than 2016 and within 60 days of the ICA-FFR procedure;
3. 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:

1. Acute myocardial infarction;
2. Unstable angina;
3. Pulmonary edema;
4. Heart function classification level III and IV (NYHA heart function classification);
5. Implantable cardioverter defibrillator (ICD);
6. Prior percutaneous coronary intervention (PCI) or pacemaker surgery;
7. Prior coronary artery bypass grafting (CABG) surgery;
8. Prior heart valve replacement;
9. Prior history of complex congenital heart disease;
10. Prior history of cardiomyopathy;
11. BMI \>35;
12. Coronary total occlusion.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level
timeFrame: through study completion, an average of 1 year
measure: Diagnostic performance including sensitivity, specificity, accuracy, PPV and NPV of DVFFR at the patient level
timeFrame: through study completion, an average of 1 year
measure: Per-vessel Pearson correlation coefficient between DVFFR and ICA-FFR values
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: Stratified analyses on different subgroups of subjects' data
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Health
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Nice
country: France
facility: Institute of Arnualt Tzanck
state: Saint-Laurent-du-Var
city: Ferrara
country: Italy
facility: University of Ferrara
city: Milan
country: Italy
facility: University of Milan
city: Warsaw
country: Poland
facility: National Institute of Cardiology
Study officials:
affiliation: Medical University of South Carolina
name: Joseph Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References: