N/A
N=4,737
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02499679 ↗Enrolled (actual)
4,737
Serious AEs
0.6%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory. — 66.9 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HeartFlow, Inc.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory. |
66.9 | — |
| SECONDARY Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management |
63.5 | — |
| SECONDARY Percentage of Participants With Invasive Catheterization Without Obstructive Disease |
43.8; 14.4 | — |
| SECONDARY Percentage of Major Adverse Coronary Events (MACE) at 90 Days |
0; 19 | — |
| SECONDARY Percentage of Individual Components of MACE at 90 Days |
0; 4; 0; 5; 0; 10 | — |
| SECONDARY Cumulative Radiation Exposure From cCTA MilliSievert (mSv) |
10.0 | — |
| SECONDARY Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan |
504; 2545; 92; 799; 115; 25 | — |
| SECONDARY Percentage of Major Adverse Coronary Events (MACE) at 1 Year |
12; 43 | — |
| SECONDARY Percentage of Individual Components of MACE at 1 Year |
7; 28; 3; 9; 2; 6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02499679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.