Acist - FFR

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study

Acist - FFR [NCT02577484]

Description: This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

Device: RXi System; Device: Pressure Wire

Primary Investigator: Sarembock

Drug/Device Information
To assess the differences, if any, between fractional flow reserve (FFR) measured by the Navvus catheter and a commercially available pressure guidewire (St. Jude Medical, Volcano)
Subjects with coronary artery disease undergoing coronary angiography
The Navvus device is a rapid exchange catheter with a pressure sensor located at the distal tip
Allows the operator to use their preferred standard 0.014-inch coronary guidewire for percutaneous coronary intervention (PCI), eliminating the need for a wire exchange
Open label (Navvus device and Volcano)
ACIST Medical Systems, Inc.
Major Inclusion and Exclusion
Subject has a clinical indication for coronary angiography
Vessel has a TIMI flow = 3
Subject has de novo lesion which physician has determined has a clinical indication for FFR measurement
No acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography
Target vessel has no angiographically visible or suspected thrombus
Target lesion is not within a bypass graft