First Patient Enrolled in CathWorks ALL-RISE Study Evaluating FFRangio System

June 28, 2023—CathWorks announced that the first patient has been enrolled in the ALL-RISE study sponsored by the company. ALL-RISE is a prospective, multicenter, randomized controlled trial (RCT) evaluating the clinical and economic benefits of the company’s FFRangio system.

The goal of the study is to appraise whether treatment using the company’s FFRangio system is noninferior to conventional pressure wire–guided treatment in patients with coronary artery disease (CAD) being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events at 1 year.

CathWorks anticipates enrolling 1,924 patients at up to 60 centers in North America, Asia, Europe, and the Middle East. Patients are randomized to either FFRangio–guided treatment or pressure wire–guided treatment.

Amir Kaki, MD, enrolled the first patient in the study at his hospital, Ascension St. John Hospital, in Detroit, Michigan.

“We have been utilizing the FFRangio system for more than a year to better guide treatment decisions for patients with CAD and have adopted it as our physiology assessment tool of choice due to the safety and efficiency benefits it offers,” commented Dr. Kaki in the company’s announcement. “We are pleased to play a pivotal role in the ALL-RISE study and hope our findings will enable more physicians to experience the same benefits we have in our lab since adopting FFRangio.”

“The enrollment of the first patient in the ALL-RISE study marks an important step forward in our collective efforts to enhance precision-based medicine to optimize the efficacy of CAD interventions,” commented Martin B. Leon, MD, Chairman of the ALL-RISE Executive Committee, in the company’s press release. “We are grateful for the collaboration of leading institutions and clinical investigators around the globe who will be generating clinical and economic evidence that will shape the future of PCIs.” Dr. Leon is Professor of Medicine at Columbia University Irving Medical Center, Director of Columbia Interventional Cardiovascular Care.

ALL-RISE is led by Study Chair, Ajay J. Kirtane, MD, at NewYork-Presbyterian/Columbia University Irving Medical Center, in New York, New York. The study’s Principal Investigators are William Fearon, MD, at Stanford University in California, and Allen Jeremias, MD, at St. Francis Hospital & Heart Center, in Roslyn, New York.

The company notes this is the first RCT in the United States to assess the outcomes of an angiography-based physiologic assessment tool.

CathWorks described how the FFRangio system obtains quick and reliable FFRangio values from routine angiograms (ie, x-rays) by using artificial intelligence and advanced computational science. This may alleviate the need for drug stimulation and invasive pressure wires.

In July 2022, CathWorks entered into a strategic partnership with Medtronic to amplify its efforts in bringing the benefits of FFRangio to more physicians and patients globally.