Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice (ADVANCE-EU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02060682|
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: Navvus Catheter FFR|
|Study Type :||Observational [Patient Registry]|
|Actual 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|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|