Clinical trial NCT02499679: Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
Official title: Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 6384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All clinically stable, symptomatic patients diagnosed with CAD by 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 EC/IRB approved informed consent will be enrolled in the registry. FFRCT shall be used in accordance with the current Instructions for Use document.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.

Exclusion Criteria:

1. cCTA showing no CAD
2. Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation
3. Any active, serious, life-threatening disease with a life expectancy of less than 1 year
4. Inability to comply with follow-up requirements

Primary outcomes:
measure: 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.
timeFrame: n/a: reclassification rate of management plan
Secondary outcomes:
measure: Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management
timeFrame: 90 days
measure: Rate of invasive catheterization without obstructive disease
timeFrame: 90 days
measure: Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization
timeFrame: 90 days
measure: Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years
timeFrame: 3 years
measure: Individual components of MACE at 90 days, 180 days, 1 - 3 years
timeFrame: 3 years
measure: Estimated cumulative medical radiation exposure
timeFrame: 1 year
measure: Resource Utilization at 90 days, 180 days, 1 - 3 years
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Duke Health
name: Manesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Health & Services
name: Jonathon Leipsic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Koen Nieman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wakayama Medical University
name: Takashi Akasaka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fairbairn TA, Dobson R, Hurwitz-Koweek L, Matsuo H, Norgaard BL, Ronnow Sand NP, Nieman K, Bax JJ, Pontone G, Raff G, Chinnaiyan KM, Rabbat M, Amano T, Kawasaki T, Akasaka T, Kitabata H, Binukrishnan S, Rogers C, Berman D, Patel MR, Douglas PS, Leipsic J. Sex Differences in Coronary Computed Tomography Angiography-Derived Fractional Flow Reserve: Lessons From ADVANCE. JACC Cardiovasc Imaging. 2020 Dec;13(12):2576-2587. doi: 10.1016/j.jcmg.2020.07.008. Epub 2020 Aug 26.
citation: Pontone G, Weir-McCall JR, Baggiano A, Del Torto A, Fusini L, Guglielmo M, Muscogiuri G, Guaricci AI, Andreini D, Patel M, Nieman K, Akasaka T, Rogers C, Norgaard BL, Bax J, Raff GL, Chinnaiyan K, Berman D, Fairbairn T, Koweek LH, Leipsic J. Determinants of Rejection Rate for Coronary CT Angiography Fractional Flow Reserve Analysis. Radiology. 2019 Sep;292(3):597-605. doi: 10.1148/radiol.2019182673. Epub 2019 Jul 23.
citation: Patel MR, Norgaard BL, Fairbairn TA, Nieman K, Akasaka T, Berman DS, Raff GL, Hurwitz Koweek LM, Pontone G, Kawasaki T, Sand NPR, Jensen JM, Amano T, Poon M, Ovrehus KA, Sonck J, Rabbat MG, Mullen S, De Bruyne B, Rogers C, Matsuo H, Bax JJ, Leipsic J. 1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 1):97-105. doi: 10.1016/j.jcmg.2019.03.003. Epub 2019 Mar 17.