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Clinical Trial Summary

PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.


Clinical Trial Description

PROPHET-FFR is a ambispective observational study enrolling patients that need invasive functional evaluation in the diagnostic workup of coronary artery disease. Clinical outcomes of patients that undergo functional assessment after PCI will be compared both to patients undergoing PCI without further evaluations and both to patients that will be deferred due to to negative functional evaluation. Since the observational nature of the study the decision to perform post-PCI physiological assessment will be left to operator's discretion. In case of post-PCI functional evaluation results that will be deemed as unsatisfactory by the operator further actions can be taken in order to optimize procedural result. The decision on this opportunity as well as the choice of the strategy to adopt are left to operator's discretion. The primary endpoint of the study is the rate of MACE defined as the composite of spontaneous MI, target vessel failure, cardiac deaths at 24 months. Follow up will be performed by telephone contact and medical records screening at 12, 24 and 36 months. Moreover data about in-hospital events will be collected including the release of myocardial damage markers, change in Creatinine, and lenght of hospital stay. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05056662
Study type Observational [Patient Registry]
Source Catholic University of the Sacred Heart
Contact Antonio Maria Leone, PI
Phone 0630155950
Email [email protected]
Status Recruiting
Phase
Start date June 4, 2020
Completion date October 1, 2025

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