Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement

UnknownOBSERVATIONAL
Enrollment

240

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Coronary Artery Disease
Interventions
DEVICE

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."

DEVICE

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.

Trial Locations (12)

10032

Columbia University Medical Center / New York Presbyterian Hospital, New York

20010

Medstart Washington Hospital Center, Washington D.C.

44195

Cleveland Cllinic Foundation, Cleveland

45219

Lindner Research Center at The Christ Hospital, Cincinnati

50266

Iowa Heart Center, West Des Moines

55433

Metropolitan Cardiology Heart and Vascular Institute, Minneapolis

55455

University of Minnesota, Minneapolis

60637

University of Chicago Medicine, Chicago

63110

Saint Louis University, St Louis

90822

Long Beach VA Medical Center, Long Beach

92037

Scripps Green Hospital, La Jolla

94305

Stanford School of Medicine, Stanford

Sponsors
All Listed Sponsors
lead

Acist Medical Systems

INDUSTRY