AngioInsight has announced the enrolment of the first patient in the SMARTFLOW clinical study, assessing AngioAI+, the company’s investigational software platform designed to assess coronary physiology from routine coronary angiographic images.
The prospective, multicentre SMARTFLOW study is co-led by Carlos Collet, director of cardiovascular imaging, physiology and translation therapeutics at the Cardiovascular Research Foundation (CRF, New York, USA) and Todd C Villines (University of Virginia School of Medicine, Charlottesville, USA), who serve as co-principal investigators.
The study aims to evaluate the diagnostic performance of AngioAI+ for providing angiography-derived fractional flow reserve (FFR) and detection of coronary microvascular disease (CMD). The study incorporates established invasive physiologic reference standards as benchmarks for success.
“This milestone marks the beginning of a new era in the angiographic assessment of coronary artery disease,” Collet commented. “The investigational software is designed to process angiograms fully automatically, without user interaction, providing a comprehensive assessment of coronary lesions while also helping to identify microvascular disease. This is an important step toward supporting physicians in making faster, more accurate diagnoses through the use of artificial intelligence.”
The first patient in the SMARTFLOW study was enrolled by Yader Sandoval and his research team at the Minneapolis Heart Institute Foundation (MHIF) at Allina Health Minneapolis Heart Institute, Abbott Northwestern Hospital (Minneapolis, USA).
“We are excited to enrol the first patient in the SMARTFLOW study and to help lead this important clinical investigation,” said Sandoval. “Building on recent advances that have established angiography-derived physiology as an important component of contemporary coronary physiology for the assessment of epicardial coronary artery disease, SMARTFLOW aims to expand physiologic assessment to include coronary microvascular disease, a major unmet clinical need. The ability to assess both epicardial and microvascular disease from routine coronary angiography could simplify physiologic evaluation and expand access to coronary functional testing.”
“The enrolment of our first patient is an important milestone for AngioInsight and reflects years of scientific collaboration, engineering innovation, and dedicated preparation by an exceptional team of physicians, researchers, engineers, and clinical partners,” said Scott Burger, CEO of AngioInsight. “SMARTFLOW represents an important step in building the clinical evidence that will support future regulatory filings for AngioAI+.”
