Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

Study Overview
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Brief Summary
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The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD) in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.

Detailed Description
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REGISTRY OBJECTIVE The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD. SPECIFIC OBJECTIVES: To determine if the availability of FFRCT, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan. To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment. To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test. To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.

Official Title
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Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT. Exclusion Criteria: cCTA showing no CAD Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation Any active, serious, life-threatening disease with a life expectancy of less than 1 year Inability to comply with follow-up requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with CAD by cCTA<br>All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA), that meet eligibility criteria, and are able and willing to participate are candidates for the ADVANCE Registry. Those patients that meet all inclusion/exclusion criteria and who sign the ethics committee (EC)/institutional review board (IRB) approved informed consent will be enrolled in the registry. FFRCT shall be used in accordance with the current Instructions for Use (IFU) document. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee. |  | n/a: reclassification rate of management plan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management |  | 90 days | 
| Rate of invasive catheterization without obstructive disease |  | 90 days | 
| Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization |  | 90 days | 
| Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years | MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization. | 3 years | 
| Individual components of MACE at 90 days, 180 days, 1 - 3 years | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization | 3 years | 
| Estimated cumulative medical radiation exposure |  | 1 year | 
| Resource Utilization at 90 days, 180 days, 1 - 3 years | Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures, treatment of MACE events, and noninvasive cardiac testing | 3 years |