Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Treatment||navvus catheter ffr|
|Sponsor||Acist Medical Systems|
|Start date||February 2014|
|End date||July 2014|
|Trial size||60 participants|
|Trial identifier||NCT02060682, EU100|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Massy, France||Hospital Privé Jacques Cartier||no longer recruiting|
|St. Denis, France||Centre Cardiologique du Nord||no longer recruiting|
|Frankfurt, Germany||Johann Wolfgang Goethe Universität||no longer recruiting|
|Fulda, Germany||Klinikum Fulda gAG||no longer recruiting|
|Mainz, Germany||Universitätsmedizin der Johannes Gutenberg-Universität Mainz||no longer recruiting|
|Milan, Italy||Ospedale San Raffaele||no longer recruiting|
|Alicante, Spain||Hospital Universitario San Juan de Alicante||no longer recruiting|
time frame: From enrollment through hospital discharge, an expected average of 1 day.
Male or female participants at least 18 years old.
Inclusion Criteria: - Subjects 18 years of age or older in whom FFR measurement is indicated to guide percutaneous coronary intervention (PCI) strategy and use of the ACIST CPM System and Navvus Catheter is attempted. Exclusion Criteria: -
|Official title||Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU|
|Principal investigator||Thierry Lefèvre, MD|
|Description||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.|
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