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

N/ACompletedNCT01943903

HeartFlow, Inc.584 enrolled

Overview

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

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: 1. 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; 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; 3. 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); 4. 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 Type

OBSERVATIONAL

Enrollment

584

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Locations (15)

HeartFlow, Inc

Redwood City, California, United States

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 Days from first test

Secondary Outcomes

Number of MACE

90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. Non-fatal MI 3. Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization

Time frame: 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.

Time frame: 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): 1. Non-invasive diagnostic tests 2. Invasive diagnostic tests 3. Coronary revascularization procedures

Time frame: 90 days from first test

Number of Participants With Medications Used by Type

Data from ClinicalTrials.gov

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