Coronary Artery Disease Clinical Trial
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
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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