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

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

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.

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.