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

The ACIST-FFR study is a prospective, open label, observational, multi-center study designed
to assess the differences, if any, between FFR measured by the Navvus catheter and a
commercially available 0.014-inch pressure guidewire (St. Jude Medical, Volcano, hereafter
referred to as the PW) in subjects with coronary artery disease (CAD) undergoing coronary
angiography. This will be accomplished by comparing the FFR measurement obtained with the
ACIST Medical Systems RXi System and Navvus catheter with the FFR measurement obtained by
using a PW within the same subject across the same target lesion at the same time.

General Inclusion Criteria:

- Subject is 18 years of age or older

- Subject has a clinical indication for coronary angiography

- Subject or subject's legal representative has the ability to understand and provide
signed consent for participating in the study

Angiographic Inclusion Criteria:

- Vessel has a TIMI flow = 3

- Subject has de novo lesion which physician has determined has a clinical indication
for FFR measurement

- RVD of the target lesion is assessed by the operator to be ≥2.25 mm.

General Exclusion Criteria:

- Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the
indication for coronary angiography

- NYHA Class 4 severe heart failure

Angiographic Exclusion Criteria:

- Target vessel has angiographically visible or suspected thrombus.

- Target lesion is within a bypass graft.

- Angiographic evidence of a dissection prior to initiation of PW measurements.

- Target vessel contains excessive tortuosity or calcification.