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

NCT04828590 | Completed FDA Device

• 1 other identifier: DVFFR ADAPT Study
• Study Type: observational
• Target: 302
• Locations: 5 countries
• Sites: 10

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

• 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.

  through study completion, an average of 1 year

• Stratified analyses on different subgroups of subjects' data

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

No intervention OTHER

Due to observational study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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%;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keya Medical: lead
• Medical University of South Carolina: collaborator

Study Sites (10)

Holy Cross Health

Fort Lauderdale, Florida, 33308, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Medical University Innsbruck

Innsbruck, Austria

Location

Institute of Arnualt Tzanck

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

Location

University of Ferrara

Ferrara, Italy

Location

University of Milan

Milan, Italy

Location

National Institute of Cardiology

Warsaw, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joseph Schoepf, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 2, 2021
• Study Start: August 10, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); PL (1); FR (1); IT (2); AU (1)