CathWorks Announces Completion of Enrollment in FAST-FFR Trial

August 16, 2018—CathWorks Limited announced that its FAST-FFR trial is fully enrolled ahead of schedule.

According to the Israel-based company, the trial is designed to evaluate the efficacy of the CathWorks FFRangio system in terms of sensitivity and specificity when compared with conventional invasive fractional flow reserve (FFR). The FAST-FFR trial is being conducted at 10 leading cardiovascular centers around the world using various coronary angiography platforms. Enrollment of all 382 patients was conducted from September 2017 to June 2018.

The noninvasive CathWorks FFRangio system is used intraprocedurally during coronary angiography. The system is designed to enable physicians to objectively and cost-effectively determine if percutaneous coronary intervention (PCI) is indicated, without an additional intervention, during the course of a routine diagnostic angiography. The CathWorks FFRangio system is in development and is not yet FDA cleared or available for sale within the United States, advised the company.

William F. Fearon, MD, who serves as the FAST-FFR trial principal investigator, commented in CathWorks' announcement, “As interventional cardiologists, we want objective multivessel physiologic measurements to make PCI decisions, which can be performed easily and with as low risk and cost as possible. We look forward to the data analysis and understanding how CathWorks FFRangio system data compares to pressure wire-derived FFR.” Dr. Fearon is Director of Interventional Cardiology at Stanford University Medical Center in Stanford, California.