Coronary Artery DiseasePLATFORMNCT01943903
The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 15 sites in 8 countries.
Trial summary
The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies… 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
- 584 participants
- Where
- 15 sitesin 8 countries
- Study dates
- Sep 2013to Dec 2015
- 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: Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD
Who may be able to join
- Age >18 years
- Providing written informed consent
- Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who:
- In Cohort 1A \& 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or
- In Cohort 1B \& 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days
- Ability to undergo cCTA
Who cannot join
- Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction.
- Prior, clinically documented myocardial infarction
- PCI prior to first test
- CABG prior to first test
- Contraindications for cCTA such as:
- Presence of pacemaker or internal defibrillator leads
Show all 21Show fewer
- Atrial Fibrillation
- Known anaphylactic allergy to iodinated contrast
- Pregnancy or unknown pregnancy status in women of childbearing potential
- Body mass index >35 kg/m2
- Contraindication to acute beta blockade
- Contraindication to acute sublingual nitrate administration
- Prosthetic heart valve
- Contraindications to FFRCT
- Complex Congenital Heart disease other than anomalous coronary origins alone
- Ventricular septal defect with known Qp/Qs>1.4
- Requiring an emergent procedure within 48 hours of presentation
- Evidence of active clinical instability, including cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, or NYHA Grade III or IV congestive heart failure or acute pulmonary edema
- Any active, serious, life-threatening disease with a life expectancy of less than 2 years
- Inability to comply with study follow-up requirements
- Current participation in any other clinical trial involving an investigational device or dictating care pathways at the time of enrollment.
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
United States3 sites
Duke University Clinical Research Institution
Durham, North Carolina, 27705
HeartFlow, Inc
Redwood City, California, 94063
Stanford University
Stanford, California, 94305
Germany3 sites
Heart Center Leipzig GmbH
Leipzig, 04289
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Deutsches Herzzentrum München - ISAResearch Centre
Munich, 80636
Austria2 sites
LKH-GRAZ-West - Department of Cardiology
Graz, A-8020
Innsbruck Medical University, Department of Radiology II
Innsbruck, A-6020
France2 sites
CHU Brest - Hopital de Cardiologie
Brest, 29609
Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France
Lyon, 69677
United Kingdom2 sites
Freeman Hospital - Therapeutics & Cardiac Research Team
Newcastle upon Tyne, NE7 7DN
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD
Read the detailed description
The OVERALL OBJECTVE of this post-market, multicenter, longitudinal, prospective, consecutive cohort study is to compare clinical outcomes, resource utilization, and quality of life (QOL) in subjects receiving standard practice evaluation and treatment versus subjects receiving FFRCT-guided evaluation and treatment in subjects with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD. Cohort 1 of this study will assess outcomes incorporating standard practice evaluation and Cohort 2 will assess outcomes incorporating FFRCT-guided evaluation. Each Cohort will be further delineated based upon initial presentation, whereas subjects presenting for initial non-invasive testing will be designated as Cohorts 1A and 2A; and subjects already referred for ICA will be designated as Cohorts 1B and 2B.
SPECIFIC OBJECTIVES for sequential cohort comparisons:
- To compare the rate of ICA documenting non-obstructive coronary artery disease, clinical outcomes, and QOL following standard practice for diagnostic and treatment planning modalities in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
- To compare resource utilization following standard practice for diagnostic and treatment pathways in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
- To provide supporting data for generating new guidelines for diagnosis and prognosis of CAD with comparative analysis of the risk stratification with the Updated Diamond-Forrester risk model (UDF);
- 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 group | Role | What they receive |
|---|---|---|
| Cohort 1 - Standard of Care | Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Cohort 1 of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. Subjects will be followed for one year after enrollment. | |
| Cohort 2 - FFRCT-guided | Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. FFRCT is a non-invasive method to evaluate the hemodynamic significance of coronary artery lesions. FFRCT calculates FFR from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. FFRCT values range between 0 and 1, and values ≤0.80 are considered hemodynamically (HD)-significant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Negative Invasive Coronary Angiography
The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis > 50% in a vessel > 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR < 0.80 in a segment distal to a stenosis in a vessel > 2.0 mm by QCA between Cohort 1 and 2.
Measured: 90 Days from first test
Secondary outcomes (4)
Number of MACE
90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:
- All cause death
- Non-fatal MI
- Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization
Measured: 90 days from first test
Number of MACE or Vascular Complications
90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population.
Measured: 90 days from first test
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days):
- Non-invasive diagnostic tests
- Invasive diagnostic tests
- Coronary revascularization procedures
Measured: 90 days from first test
Number of Participants With Medications Used by Type
Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days)
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
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 (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Gianluca Pontone, MD, Principal investigator, Centro Cardiologico MonzinoPamela Douglas, MD, Principal investigator, Duke UniversityBernard de Bruyne, MD, PHD, Principal investigator, Cardiovascular Center AalstMark Hlatky, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943903
- Sponsor's protocol ID
- CP-903-003
- Acronym
- PLATFORM
- Status last verified
- Aug 2025
- First submitted
- 10 Sep 2013
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.
PubMed 27470449Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.
PubMed 26475205
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
- ClinicalTrials.gov ID
- NCT01943903
- Acronym / sponsor ID
- PLATFORM / CP-903-003
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD
Detailed description
The OVERALL OBJECTVE of this post-market, multicenter, longitudinal, prospective, consecutive cohort study is to compare clinical outcomes, resource utilization, and quality of life (QOL) in subjects receiving standard practice evaluation and treatment versus subjects receiving FFRCT-guided evaluation and treatment in subjects with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD. Cohort 1 of this study will assess outcomes incorporating standard practice evaluation and Cohort 2 will assess outcomes incorporating FFRCT-guided evaluation. Each Cohort will be further delineated based upon initial presentation, whereas subjects presenting for initial non-invasive testing will be designated as Cohorts 1A and 2A; and subjects already referred for ICA will be designated as Cohorts 1B and 2B.
SPECIFIC OBJECTIVES for sequential cohort comparisons:
- To compare the rate of ICA documenting non-obstructive coronary artery disease, clinical outcomes, and QOL following standard practice for diagnostic and treatment planning modalities in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
- To compare resource utilization following standard practice for diagnostic and treatment pathways in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
- To provide supporting data for generating new guidelines for diagnosis and prognosis of CAD with comparative analysis of the risk stratification with the Updated Diamond-Forrester risk model (UDF);
- 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Standard of Care | – | –Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Cohort 1 of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. Subjects will be followed for one year after enrollment. |
| Cohort 2 - FFRCT-guided | – | –Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. FFRCT is a non-invasive method to evaluate the hemodynamic significance of coronary artery lesions. FFRCT calculates FFR from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. FFRCT values range between 0 and 1, and values ≤0.80 are considered hemodynamically (HD)-significant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD
Key inclusion criteria (6 listed)
- Age >18 years
- Providing written informed consent
- Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who:
- In Cohort 1A \& 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or
- In Cohort 1B \& 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days
Key exclusion criteria (21 listed)
- Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction.
- Prior, clinically documented myocardial infarction
- PCI prior to first test
- CABG prior to first test
- Contraindications for cCTA such as:
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
Number of Participants With Negative Invasive Coronary Angiography
Time frame: 90 Days from first test
The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis > 50% in a vessel > 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR < 0.80 in a segment distal to a stenosis in a vessel > 2.0 mm by QCA between Cohort 1 and 2.
4 secondary outcomes
Number of MACE
Time frame: 90 days from first test
Number of MACE or Vascular Complications
Time frame: 90 days from first test
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
Time frame: 90 days from first test
Number of Participants With Medications Used by Type
Time frame: at 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27470449Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.
- Derived from this study: PubMed 26475205Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.
- 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM StudyLink provided by the sponsor.
- Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORMLink 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.
Gianluca Pontone, MD principal investigator
Centro Cardiologico Monzino
Pamela Douglas, MD principal investigator
Duke University
Bernard de Bruyne, MD, PHD principal investigator
Cardiovascular Center Aalst
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 15 sites in 8 countries.
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 6 inclusion and 21 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Austria, France, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 5 Sep 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?
Number of Participants With Negative Invasive Coronary Angiography (time frame: 90 Days from first test). 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 NCT01943903, which also lists 2 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 5 Sep 2025.