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

Coronary Artery Disease Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828590
• Other study ID #: DVFFR ADAPT Study
• Status: Completed
• Start date: August 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Keya Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Other:
• No intervention
Due to observational study

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
France	Institute of Arnualt Tzanck	Nice	Saint-Laurent-du-Var
Italy	University of Ferrara	Ferrara
Italy	University of Milan	Milan
Poland	National Institute of Cardiology	Warsaw
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Holy Cross Health	Fort Lauderdale	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Keya Medical	Medical University of South Carolina

Countries where clinical trial is conducted

United States,  Austria,  France,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	through study completion, an average of 1 year
Primary	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.	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.	through study completion, an average of 1 year
Secondary	Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level	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.	through study completion, an average of 1 year
Secondary	Diagnostic performance including sensitivity, specificity, accuracy, PPV and NPV of DVFFR at the patient level	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.	through study completion, an average of 1 year
Secondary	Per-vessel Pearson correlation coefficient between DVFFR and ICA-FFR values	Correlation between CT-derived DVFFR values and wire-measured ICA-FFR values will be evaluated at the vessel level.	through study completion, an average of 1 year
Secondary	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.	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.	through study completion, an average of 1 year
Secondary	Stratified analyses on different subgroups of subjects' data	Stratified analyses on different subgroups of subjects' data, ranging from patient demographics and disease conditions.	through study completion, an average of 1 year