CathWorks FFRangio System’s ALL-RISE Trial Completes Enrollment

January 6, 2025—CathWorks recently announced the completion of enrollment for the ALL-RISE randomized controlled trial, evaluating the clinical and economic benefits of the CathWorks FFRangio system in diagnosing and treating coronary artery disease.

According to the company, the ALL-RISE trial is composed of > 1,924 patients enrolled across 59 sites in North America, Asia, Europe, and the Middle East. Patients presenting with coronary stenoses of intermediate significance and requiring physiology assessment were randomized to receive either FFRangio-guided treatment or invasive pressure wire-guided treatment.

In June 2023, the company announced that Amir Kaki, MD, enrolled the first patient in the study at Ascension St. John Hospital in Detroit, Michigan.

ALL-RISE is led by study chair Ajay J. Kirtane, MD, and principal investigators William Fearon, MD, and Allen Jeremias, MD.

“On behalf of the study executive committee, we would like to congratulate and thank all the global investigators, study coordinators, and patients who collectively enabled this incredible accomplishment,” commented the three study leaders in a joint statement in the CathWorks press release. “The high level of engagement and record speed of enrollment parallel the growing adoption of FFRangio globally. We look forward to sharing the results of this landmark study after clinical follow-up is completed.”

Dr. Kirtane is from NewYork-Presbyterian/Columbia University Irving Medical Center in New York, New York. Dr. Fearon is from Stanford University in Stanford, California. Dr. Jeremias is from St. Francis Hospital & Heart Center in Roslyn, New York.

FDA 510(k) clearance of the FFRangio system, which is intended to deliver quick and precise fractional flow reserve (FFR) guidance to help optimize decision-making during percutaneous coronary intervention therapy, was announced in December 2018. In May 2024, CathWorks announced that the FFRangio system was approved under the European Union Medical Device Regulation 2017/745, replacing the previous Medical Device Directive 93/42/EEC.