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

• ClinicalTrials.gov Identifier: NCT04828590
• Recruitment Status: Completed
• First Posted: April 2, 2021
• Last Update Posted: April 22, 2022
• Sponsor: Keya Medical
• Collaborator: Medical University of South Carolina
• Information provided by (Responsible Party): Keya Medical

Study Description

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.

Condition or disease	Intervention/treatment
Coronary Artery Disease; Myocardial Ischemia	Other: No intervention

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 302 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
• Actual Study Start Date: August 10, 2020
• Actual Primary Completion Date: December 1, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis; Patients' datasets with suspected CAD containing at least one 30%-90% coronary CTA stenosis; and ICA-FFR was measured on vessels with diameters greater than 2 mm will be analyzed. Diagnostic performance based on CT-derived FFR using DVFFR software will be compared with the diagnostic performance from ICA-FFR measurements.

Other: No intervention; Due to observational study

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis.

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.

Contacts and Locations

Locations

United States, Florida

Holy Cross Health

Fort Lauderdale, Florida, United States, 33308

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29407

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Austria

Medical University Innsbruck

Innsbruck, Austria

France

Institute of Arnualt Tzanck

Nice, Saint-Laurent-du-Var, France, 06700

Italy

University of Ferrara

Ferrara, Italy

University of Milan

Milan, Italy

Poland

National Institute of Cardiology

Warsaw, Poland

Sponsors and Collaborators

Keya Medical

Medical University of South Carolina

Investigators

• Principal Investigator: Joseph Schoepf, MD; Medical University of South Carolina

More Information

• Responsible Party: Keya Medical
• ClinicalTrials.gov Identifier: NCT04828590
• Other Study ID Numbers: DVFFR ADAPT Study
• First Posted: April 2, 2021
• Last Update Posted: April 22, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

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