NCT02499679

Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,737 (actual)
• Sponsor: HeartFlow, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. 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. 2. To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment. 3. To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test. 4. 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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-02-01
• Completion: 2019-05-01
• First posted: 2015-07-16
• Last updated: 2025-07-30
• Results posted: 2025-07-30