Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
NCT ID: NCT02499679
Last Updated: 2025-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
4737 participants
OBSERVATIONAL
2015-07-31
2019-05-31
Brief Summary
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Detailed Description
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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 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients diagnosed with CAD by cCTA
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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HeartFlow, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Manesh Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Jonathon Leipsic, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Health & Services
Koen Nieman, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Takashi Akasaka, MD
Role: PRINCIPAL_INVESTIGATOR
Wakayama Medical University
References
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Dundas J, Leipsic J, Fairbairn T, Ng N, Sussman V, Guez I, Rosenblatt R, Hurwitz Koweek LM, Douglas PS, Rabbat M, Pontone G, Chinnaiyan K, de Bruyne B, Bax JJ, Amano T, Nieman K, Rogers C, Kitabata H, Sand NPR, Kawasaki T, Mullen S, Huey W, Matsuo H, Patel MR, Norgaard BL, Ahmadi A, Tzimas G. Interaction of AI-Enabled Quantitative Coronary Plaque Volumes on Coronary CT Angiography, FFRCT, and Clinical Outcomes: A Retrospective Analysis of the ADVANCE Registry. Circ Cardiovasc Imaging. 2024 Mar;17(3):e016143. doi: 10.1161/CIRCIMAGING.123.016143. Epub 2024 Mar 12.
Gulsin GS, Tzimas G, Holmes KR, Takagi H, Sellers SL, Blanke P, Koweek LMH, Norgaard BL, Jensen J, Rabbat MG, Pontone G, Fairbairn TA, Chinnaiyan KM, Douglas PS, Huey W, Matsuo H, Sand NPR, Nieman K, Bax JJ, Amano T, Kawasaki T, Akasaka T, Rogers C, Berman DS, Patel MR, De Bruyne B, Mullen S, Leipsic JA. Impact of Coronary CT Angiography-derived Fractional Flow Reserve on Downstream Management and Clinical Outcomes in Individuals with and without Diabetes. Radiol Cardiothorac Imaging. 2023 Oct 19;5(5):e220276. doi: 10.1148/ryct.220276. eCollection 2023 Oct.
Madsen KT, Norgaard BL, Ovrehus KA, Jensen JM, Parner E, Grove EL, Fairbairn TA, Nieman K, Patel MR, Rogers C, Mullen S, Mickley H, Rohold A, Botker HE, Leipsic J, Sand NPR. Prognostic Value of Coronary CT Angiography-derived Fractional Flow Reserve on 3-year Outcomes in Patients with Stable Angina. Radiology. 2023 Sep;308(3):e230524. doi: 10.1148/radiol.230524.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry
1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry
Other Identifiers
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CP-905-001
Identifier Type: -
Identifier Source: org_study_id
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