Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice (ADVANCE-EU)
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Day|
|Official Title:||Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU|
- Procedural Success [ Time Frame: From enrollment through hospital discharge, an expected average of 1 day. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Navvus Catheter FFR
The Navvus Catheter is a rapid exchange microcatheter with a pressure sensor at the distal tip that measures Fractional Flow Reserve measurements to guide PCI treatment strategy.
Device: Navvus Catheter FFR
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02060682
|Hospital Privé Jacques Cartier|
|Centre Cardiologique du Nord|
|St. Denis, France|
|Johann Wolfgang Goethe Universität|
|Klinikum Fulda gAG|
|Universitätsmedizin der Johannes Gutenberg-Universität Mainz|
|Ospedale San Raffaele|
|Hospital Universitario San Juan de Alicante|
|Principal Investigator:||Thierry Lefèvre, MD||Hospital Privé Jacques Cartier|