Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice (ADVANCE-EU)
|ClinicalTrials.gov Identifier: NCT02060682|
Recruitment Status : Unknown
Verified July 2014 by Acist Medical Systems.
Recruitment status was: Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: Navvus Catheter FFR|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|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|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2014|
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).
- Procedural Success [ Time Frame: From enrollment through hospital discharge, an expected average of 1 day. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|