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Completed

NCT Number: NCT02499679

Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: at 90 days

    The reclassification rate of management plans was assessed by the blinded independent review committee and local physician teams separately. These evaluations are meant to assess the potential impact of FFRCT on downstream testing and clinical decision making but were not be used to determine actual patient care. This endpoint is aimed at determining the incremental value of FFRCT over coronary CTA alone in the management of stable angina.

    FFRCT is non-invasive method to determine FFR which computes the hemodynamic significance of CAD (FFRCT) from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions (Taylor 2013).

Secondary outcomes

  1. Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management

    Time frame: at 90 days

    Coronary computed tomography angiography-derived fractional flow reserve resulted in revision of the clinical management plan as determined by the site investigators.

  2. Percentage of Participants With Invasive Catheterization Without Obstructive Disease

    Time frame: At 90 days

    Invasive catheterization without obstructive disease was measured by either site read coronary angiogram showing no stenosis of ≥ 50% or no invasively-measured FFR ≤ 0.80 in a segment distal to a stenosis.

  3. Percentage of Major Adverse Coronary Events (MACE) at 90 Days

    Time frame: 90 days

    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.

  4. Percentage of Individual Components of MACE at 90 Days

    Time frame: 90 days

    Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization

  5. Cumulative Radiation Exposure From cCTA MilliSievert (mSv)

    Time frame: Baseline

    Cumulative radiation exposure calculated in non-invasive coronary diagnostic tests: cCTA effective radiation dose. Effective radiation dose measured as the product of dose-length product times for conversion coefficient for the chest (K = 0.026 mSv/mGy·cm).

  6. Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan

    Time frame: 90 days

    Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures and noninvasive cardiac testing. Site treating physician recommended clinical management strategies following coronary computed tomography angiography-derived fractional flow reserve.

  7. Percentage of Major Adverse Coronary Events (MACE) at 1 Year

    Time frame: 1 year

    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.

  8. Percentage of Individual Components of MACE at 1 Year

    Time frame: 1 year

    Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization

Sponsors and collaborators

Lead sponsor

HeartFlow, Inc.

Industry

Registry information

Official study title

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

Acronym: ADVANCE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2015
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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