To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.
Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.
Study Type
OBSERVATIONAL
Enrollment
100
St. Francis Hospital The Heart Center
New York, New York, United States
RECRUITINGDepartment of Cardiology, University Hospital
Lille, France
RECRUITINGInstitute of Cardiology, Catholic University of the Sacred Heart
Rome, Italy
Diagnostic accuracy of Pd/Pamin vs FFR
Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.
Time frame: baseline
Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
ROC analysis using FFR as reference
Time frame: baseline
Feasibility of Pd/Pamin measurements
Description of how often can Pd/Pamin can be measured accurately
Time frame: Baseline
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Hospital Prof. Doutor Fernando da Fonseca
Amadora, Portugal
RECRUITINGCentro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz
Carnaxide, Portugal
RECRUITINGCentro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta
Lisbon, Portugal
RECRUITING