Pie Medical Imaging Caas vFFR FAST III Trial Completes Enrollment

June 18, 2024—Pie Medical Imaging, a Netherlands-based cardiac imaging company, announced the completion of enrollment in the FAST III trial. Investigators have enrolled 2,228 patients at > 35 centers.

According to the company, FAST III is a multicenter randomized clinical trial investigating use of angiography-based vessel fractional flow reserve (vFFR) with the company’s Caas vFFR in patients undergoing coronary revascularization procedures. vFFR assesses whether a coronary artery stenosis is functionally significant and requires revascularization.

Pie stated that FAST III is a noninferiority trial comparing a Caas vFFR–guided strategy to an FFR-guided strategy to guide coronary revascularization. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year postrandomization.

The investigator-initiated trial is led by Joost Daemen, MD, a cardiologist at the Thoraxcenter at Erasmus University Medical Center in Rotterdam, the Netherlands.

“The FAST III trial is aimed to establish the role of vFFR to coronary revascularization in patients with intermediate coronary artery lesions,” commented Dr. Daeman in Pie Medical Imaging’s press release. “An important milestone was reached Friday, May 31, 2024, when the last patient was enrolled. The next phase will consist of close follow-up of all patients who generously agreed to participate in the important trial. We hope to present our findings by the end of 2025.”

The FAST III trial is sponsored by ECRI, the European Cardiovascular Research Institute in Rotterdam, and funded by research grants from Pie Medical Imaging and Siemens Healthineers.

The company noted that FAST III aims to establish the role of Caas vFFR in routine clinical practice.