January 12, 2017 — Acist Medical Systems Inc. announced that enrollment is complete for its Fractional Flow Reserve (FFR) Study – Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve measurement. The study, which began in November 2015, included 240 patients at 12 sites across the United States. Final results are expected to be released in mid-2017.
The purpose of this large, prospective, multi-center study is to advance the clinical understanding of FFR technologies by comparing FFR measurements obtained using the Navvus catheter to those obtained using a commercially available pressure guide wire. The co-principal investigators are Matthew Price, M.D., Scripps Clinic, La Jolla, Calif., and William Fearon, M.D., Stanford University, Palo Alto, Calif.
"We are excited about the completion of enrollment in this important clinical trial," said Fearon. "We look forward to analyzing the data to better understand how we can most effectively utilize this exciting technology to help our patients."
The study is specifically evaluating measurement accuracy, incidence of drift, and device success in patients with single or multi-vessel coronary artery disease where FFR is clinically indicated. 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. ACIST FFR will also evaluate measurement accuracy in vessels as small as 2.25 mm.
For more information: www.acist.com