Enrollment Completed for ACIST-FFR Multicenter Study

January 11, 2017—Acist Medical Systems, Inc. announced that enrollment is complete for its Assessment of Catheter-Based Interrogation and Standard Techniques for Fractional Flow Reserve (ACIST-FFR) study of FFR measurement using the company's Navvus catheter. 

Beginning in November 2015, the ACIST-FFR study enrolled 240 patients at 12 sites across the United States. Final results are expected to be released in mid-2017. The Coprincipal Investigators are Matthew Price, MD, and William Fearon, MD. Dr. Price is with Scripps Clinic in La Jolla, California, and Dr. Fearon is with Stanford University in Palo Alto, California.

According to the company, the large, prospective, multicenter ACIST-FFR study is comparing FFR measurements obtained using the Navvus catheter versus a commercially available pressure guidewire. The study is specifically evaluating measurement accuracy, incidence of drift, and device success in patients with single or multivessel coronary artery disease where FFR is clinically indicated. ACIST-FFR will also evaluate measurement accuracy in vessels as small as 2.25 mm.

The results of the study, combined with the ACCESS-NZ trial results, will provide important data regarding how this technology affects patient care while demonstrating its clinical usefulness in everyday practice, stated the company.