240
Participants
Start Date
November 30, 2015
Primary Completion Date
January 31, 2017
Study Completion Date
January 31, 2017
RXi System
"Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.~Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The RXi system includes a single use catheter (Navvus) with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired by the guide catheter via an interface to the hospital hemodynamic monitor.~The Navvus catheter interfaces to the RXi system console which includes embedded software, a user interface touch screen and associated electronics."
Pressure Wire
Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.
Columbia University Medical Center / New York Presbyterian Hospital, New York
Medstart Washington Hospital Center, Washington D.C.
Cleveland Cllinic Foundation, Cleveland
Lindner Research Center at The Christ Hospital, Cincinnati
Iowa Heart Center, West Des Moines
Metropolitan Cardiology Heart and Vascular Institute, Minneapolis
University of Minnesota, Minneapolis
University of Chicago Medicine, Chicago
Saint Louis University, St Louis
Long Beach VA Medical Center, Long Beach
Scripps Green Hospital, La Jolla
Stanford School of Medicine, Stanford
Lead Sponsor
Acist Medical Systems
INDUSTRY