Coronary Artery DiseaseADVANCENCT02499679

Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

An observational study of Coronary Artery Disease, run by HeartFlow, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
How many people: 4,737 participants
Where: No sites listed yet
Study dates: Jul 2015to May 2019
How long will I take part?: 1 Year
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

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

Read the 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:

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.

Conditions: Coronary Artery Disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02499679
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: at 90 days

Secondary outcomes (8)

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.
Measured: at 90 days
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015May 2019

First posted16 Jul 2015 (estimated)
Study startJul 2015
Primary completionFeb 2019
Study completionMay 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 4,737 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT02499679
Sponsor's protocol ID: CP-905-001
Acronym: ADVANCE
Status last verified: Nov 2024
First submitted: 13 Jul 2015
Last updated: 30 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 38483246
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.
PubMed 38469689
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.
PubMed 37908552
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.
PubMed 37698477
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.
PubMed 32861656
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.
PubMed 31335283
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.
PubMed 31005540

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)
ClinicalTrials.gov ID: NCT02499679
Acronym / sponsor ID: ADVANCE / CP-905-001
Conditions: Coronary Artery Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 4,737 participants (actual)
Lead sponsor: HeartFlow, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2015 (actual)
Primary completion: Feb 2019 (actual)
Study completion: May 2019 (actual)
First posted: 16 Jul 2015 (estimated)
Results: Posted 30 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).

8 secondary outcomes

Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management
Time frame: at 90 days
Percentage of Participants With Invasive Catheterization Without Obstructive Disease
Time frame: At 90 days
Percentage of Major Adverse Coronary Events (MACE) at 90 Days
Time frame: 90 days
Percentage of Individual Components of MACE at 90 Days
Time frame: 90 days
Cumulative Radiation Exposure From cCTA MilliSievert (mSv)
Time frame: Baseline
Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan
Time frame: 90 days
Percentage of Major Adverse Coronary Events (MACE) at 1 Year
Time frame: 1 year
Percentage of Individual Components of MACE at 1 Year
Time frame: 1 year

Results and safety

Results posted to the registry on 30 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients Diagnosed With CAD by cCTA+FFRCT	4,737	4,737

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Reclassification Rate by Core Lab n = 4737
Value	66.9 (64.8 to 67.6)

Population analysed: The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Clinical Events at 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Receiving cCTA and FFRCT >0.80	12 of 4,737 (0.3%)	80 of 1,591 (5%)	7 of 4,737
Patients Receiving cCTA and FFRCT≤0.80	43 of 4,737 (0.9%)	1,036 of 3,137 (33%)	28 of 4,737

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38483246Holmes 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.
Derived from this study: PubMed 38469689Dundas 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.
Derived from this study: PubMed 37908552Gulsin 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.
Derived from this study: PubMed 37698477Madsen 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.
Derived from this study: PubMed 32861656Fairbairn 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.
Derived from this study: PubMed 31335283Pontone 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.
Derived from this study: PubMed 31005540Patel 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.
Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE RegistryLink provided by the sponsor.
1-Year Impact on Medical Practice and Clinical Outcomes of FFRCT: The ADVANCE RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manesh Patel, MD principal investigator

Duke Health

Jonathon Leipsic, MD principal investigator

Providence Health & Services

Koen Nieman, MD principal investigator

Erasmus Medical Center

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by HeartFlow, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499679, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.