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

NCT ID: NCT04828590

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 302 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-10
• Study Completion Date: 2021-12-31

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No intervention

Intervention Type: OTHER

Due to observational study

Interventions

No intervention

Due to observational study

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Keya Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Holy Cross Health

Fort Lauderdale, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Medical University Innsbruck

Innsbruck, , Austria

Institute of Arnualt Tzanck

Nice, Saint-Laurent-du-Var, France

University of Ferrara

Ferrara, , Italy

University of Milan

Milan, , Italy

National Institute of Cardiology

Warsaw, , Poland

Countries

United States; Austria; France; Italy; Poland

Other Identifiers

DVFFR ADAPT Study

Identifier Type: -

Identifier Source: org_study_id