ACIST Medical Systems has announced that enrolment has been completed in its ACIST-FFR study—Assessment of catheter-based interrogation and standard techniques for fractional flow reserve measurement—which is a multicentre trial that began in November 2015 and includes 240 patients at 12 sites across the USA. Final results are expected to be released in mid-2017.
The purpose of this large, prospective, multicentre study is to compare fractional flow reserve (FFR) measurements obtained using the Navvus catheter (ACIST Medical Systems) with those taken with a commercially available pressure guidewire. The co-principal investigators are Matthew Price (Scripps Clinic, La Jolla, USA) and William Fearon (Stanford University, Palo Alto, USA).
Specifically, the study is evaluating measurement accuracy, incidence of drift, and device success in patients with single- or multi-vessel coronary artery disease where FFR is clinically indicated. A press release reports that the results of the study, combined with the ACCESS-NZ trial results, will provide important data regarding how this technology impacts patient care while demonstrating its clinical usefulness in everyday practice. Additionally, ACIST FFR will also evaluate measurement accuracy in vessels as small as 2.25mm.
Fearon comments: “We are excited about the completion of enrolment in this important clinical trial. We look forward to analysing the data to better understand how we can most effectively utilize this exciting technology to help our patients.”
