This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.
There are no protocol-specific procedural requirements for this registry. Enrolled subjects will undergo a diagnostic angiography procedure including an FFR measurement with the CPM System and NAVVUS Catheter according to the center standard of care and the Instructions for Use of the CPM System and Navvus Catheter. Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Study Type
OBSERVATIONAL
Enrollment
60
Navvus Catheter provides Fractional Flow Reserve (FFR) measurement for each lesion identified according to standard of care of the center and the Instructions for Use (IFU).
Hospital Privé Jacques Cartier
Massy, France
Centre Cardiologique du Nord
Saint-Denis, France
Johann Wolfgang Goethe Universität
Frankfurt, Germany
Klinikum Fulda gAG
Fulda, Germany
Procedural Success
Procedural success is defined as the ability of the ACIST CPM System and NAVVUS Catheter to acquire FFR measurement without adverse device effect or device malfunction.
Time frame: From enrollment through hospital discharge, an expected average of 1 day.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Ospedale San Raffaele
Milan, Italy
Hospital Universitario San Juan de Alicante
Alicante, Spain