Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management | Coronary computed tomography angiography-derived fractional flow reserve resulted in revision of the clinical management plan as determined by the site investigators. | at 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38483246 | Derived | Holmes KR, Gulsin GS, Fairbairn TA, Hurwitz-Koweek L, Matsuo H, Norgaard BL, Jensen JM, Sand NR, Nieman K, Bax JJ, Pontone G, Chinnaiyan KM, Rabbat MG, Amano T, Kawasaki T, Akasaka T, Kitabata H, Rogers C, Patel MR, Payne GW, Leipsic JA, Sellers SL. Impact of Smoking on Coronary Volume-to-Myocardial Mass Ratio: An ADVANCE Registry Substudy. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e220197. doi: 10.1148/ryct.220197. | |
| 38469689 |
| Label | URL |
|---|---|
| Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry | View source |
Not provided
The ADVANCE Registry screened a total of 5,083 patients, and 4,893 of them had coronary CTA submitted for FFRCT analysis. Of these submitted, 4,737 (96.80%) were of sufficient image quality for FFRCT analysis.
All clinically stable, symptomatic patients diagnosed with CAD by coronary CTA that meet the following eligibility criteria are candidates for enrollment in the ADVANCE Registry: age >18 years, ability to provide informed consent, and meet eligibility criteria for FFRCT based on CAD, with an anatomical stenosis >25%, diagnosed on coronary CTA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Patients Diagnosed With CAD by cCTA+FFRCT | All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA) and FFRCT (Fractional Flow Reserve derived from coronary computed tomography angiography). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There was no significant difference between subject group demographics or risk factors for those receiving CCTA alone vs. CCTA plus FFRCT. Information represented in this table is for all subjects with FFRCT results and data available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Obstructive CAD will be defined as luminal diameter stenosis >50% by invasive angiography visual assessment or non-invasive cCTA, or invasively measured FFR of ≤0.80. cCTA is defined as coronary computed tomographic angiography. FFR (Fractional Flow Reserve) is defined as the ratio of the mean distal intracoronary arterial pressure, (Pd) to the mean arterial pressure (Pa) under conditions of adenosine induced maximal hyperemia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There was no significant difference between subject group demographics or risk factors for those receiving CCTA alone vs. CCTA plus FFRCT. Information represented in this table is for all subjects with FFRCT results. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management. | Posted | Number | 95% Confidence Interval | percentage of participants | at 90 days |
|
Clinical Events at 1 year
Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test and further patient management therefore adverse event information is reported based only on the standard of care index procedure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving cCTA and FFRCT >0.80 | All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA) and received FFRCT analysis results. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (any cause) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revascularization | Cardiac disorders | Systematic Assessment | Revascularization: CABG - coronary artery bypass graft, PCI - percutaneous coronary intervention. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Mullen | HeartFlow | 650-241-1221 | smullen@heartflow.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2017 | Feb 28, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of Participants With Invasive Catheterization Without Obstructive Disease |
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. |
| At 90 days |
| Percentage of Major Adverse Coronary Events (MACE) at 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. | 90 days |
| Percentage of Individual Components of MACE at 90 Days | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization | 90 days |
| Cumulative Radiation Exposure From cCTA MilliSievert (mSv) | 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). | Baseline |
| Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan | 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. | 90 days |
| Percentage of Major Adverse Coronary Events (MACE) at 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. | 1 year |
| Percentage of Individual Components of MACE at 1 Year | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization | 1 year |
| Derived |
| 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. |
| 37908552 | 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. |
| 37698477 | 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. |
| 32861656 | 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. |
| 31335283 | 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. |
| 31005540 | 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. |
| 1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE Registry | View source |
There was no significant difference between subject group demographics or risk factors for those receiving CCTA alone vs. CCTA plus FFRCT. Information represented in this table is for all subjects with FFRCT results. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | There was no significant difference between subject group demographics or risk factors for those receiving CCTA alone vs. CCTA plus FFRCT. Information represented in this table is for all subjects with FFRCT results. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetus mellitus | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Angina status | There was no significant difference between subject group demographics or risk factors for those receiving CCTA alone vs. CCTA plus FFRCT. Information represented in this table is for all subjects with FFRCT results. | Count of Participants | Participants |
|
| OG000 | Reclassification Rate by Core Lab | For each enrolled patient, the endpoint review committee used data from coronary CTA and FFRCT, along with the clinical data such as medical history and demographics to determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The management plan recommended by the committee was compared with the therapy that the patient received, as determined by his or her local team of physicians. |
|
|
| Secondary | Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management | Coronary computed tomography angiography-derived fractional flow reserve resulted in revision of the clinical management plan as determined by the site investigators. | All participants who were enrolled in the study and received cCTA and FFRCT analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | at 90 days |
|
|
|
| Secondary | Percentage of Participants With Invasive Catheterization Without Obstructive Disease | 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. | The rate of anatomically defined 'non-obstructive' disease at ICA (no stenosis defined as >50% at ICA) | Posted | Number | percentage of participants | At 90 days |
|
|
|
| Secondary | Percentage of Major Adverse Coronary Events (MACE) at 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. | MACE: Major adverse cardiac event (MI, Death, Hospitalization for ASC and urgent revascularization). | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percentage of Individual Components of MACE at 90 Days | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization | MI - myocardial infarction ACS - acute coronary syndrome | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Cumulative Radiation Exposure From cCTA MilliSievert (mSv) | 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). | All patients referred for clinical consecutive coronary CT angiography who had FFRCT analysis performed | Posted | Mean | Standard Deviation | mSv | Baseline |
|
|
|
| Secondary | Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan | 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. | All stable patients who undergo cCTA and are diagnosed with CAD. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Percentage of Major Adverse Coronary Events (MACE) at 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. | MACE: Major adverse cardiac event (MI, Death, Hospitalization for ASC and urgent revascularization). | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Percentage of Individual Components of MACE at 1 Year | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization | MI - myocardial infarction ACS - acute coronary syndrome | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 7 |
| 4,737 |
| 12 |
| 4,737 |
| 80 |
| 1,591 |
| EG001 | Patients Receiving cCTA and FFRCT≤0.80 | All clinically stable, symptomatic patients diagnosed with CAD by coronary computed tomography angiography (cCTA) and received FFRCT analysis results. | 28 | 4,737 | 43 | 4,737 | 1,036 | 3,137 |
| MI | Cardiac disorders | Systematic Assessment | MI - myocardial infarction |
|
| ACS leading to urgent hospitalization and revascularization | Cardiac disorders | Systematic Assessment | ACS - acute coronary syndrome |
|
|
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Death |
|
| Title | Measurements |
|---|---|
|
| CABG |
|
| ACS leading to unplanned hospitalization and revascularization |
|