Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

NCT02499679 | Completed Results DMC

• 1 other identifier: CP-905-001
• Study Type: observational
• Target: 4,737
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

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.

  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).

  at 90 days

Secondary Outcomes (8)

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

  at 90 days

• Percentage of Participants With Invasive Catheterization Without Obstructive Disease

  At 90 days

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

  90 days

• Percentage of Individual Components of MACE at 90 Days

  90 days

• Cumulative Radiation Exposure From cCTA MilliSievert (mSv)

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead

Related Publications (6)

• 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.

  PMID: 38469689 DERIVED

• 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.

  PMID: 37908552 DERIVED

• 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.

  PMID: 37698477 DERIVED

• 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.

  PMID: 32861656 DERIVED

• 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.

  PMID: 31335283 DERIVED

• 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.

  PMID: 31005540 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sarah Mullen
• Organization: HeartFlow

smullen@heartflow.com

650-241-1221

Study Officials

• Manesh Patel, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

• Jonathon Leipsic, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

• Koen Nieman, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Takashi Akasaka, MD

  Wakayama Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 16, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2024-11