The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)

NCT01943903 | Completed Results DMC

• 1 other identifier: CP-903-003
• Study Type: observational
• Target: 584
• Locations: 8 countries
• Sites: 15

Brief 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 are most effective and efficient in the diagnosis of CAD

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  90 Days from first test

Secondary Outcomes (4)

• Number of MACE

  90 days from first test

• Number of MACE or Vascular Complications

  90 days from first test

• Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days

  90 days from first test

• Number of Participants With Medications Used by Type

  at 90 days

Study Arms (2)

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.

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

Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Duke Clinical Research Institute: collaborator

Study Sites (15)

HeartFlow, Inc

Redwood City, California, 94063, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Duke University Clinical Research Institution

Durham, North Carolina, 27705, United States

Location

LKH-GRAZ-West - Department of Cardiology

Graz, A-8020, Austria

Location

Innsbruck Medical University, Department of Radiology II

Innsbruck, A-6020, Austria

Location

Cardiovascular Center Aalst

Aalst, Belgium

Location

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

CHU Brest - Hopital de Cardiologie

Brest, 29609, France

Location

Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France

Lyon, 69677, France

Location

Heart Center Leipzig GmbH

Leipzig, 04289, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Deutsches Herzzentrum München - ISAResearch Centre

Munich, 80636, Germany

Location

Centro Cardiologico Monzino

Milan, 20154, Italy

Location

Freeman Hospital - Therapeutics & Cardiac Research Team

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27470449 DERIVED

• Hlatky 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.

  PMID: 26475205 DERIVED

Related Links

• 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study
• Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM

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: VP, Clinical
• Organization: HeartFlow

smullen@heartflow.com

408-314-2335

Study Officials

• Gianluca Pontone, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

• Pamela Douglas, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Bernard de Bruyne, MD, PHD

  Cardiovascular Center Aalst

  PRINCIPAL INVESTIGATOR

• Mark Hlatky, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-08

Locations

AU (2); BE (1); US (3); FR (2); GB (2); IT (1); DK (1); DE (3)