AngioInsight has announced the upcoming launch of its pivotal clinical study, SMARTFLOW, to evaluate the diagnostic accuracy and effectiveness of its AngioAI+ platform.
AngioAI+ is a software only platform which leverages artificial intelligence (AI) and machine learning (ML) algorithms to enhance the precision and efficiency of angiography image interpretation. AngioAI+ is being designed to provide real-time 3D reconstruction, non-invasive fractional flow reserve (FFR) estimations, stenosis measurements, and to identify the presence of coronary microvascular disease (CMD).
The SMARTFLOW study is a key milestone in AngioInsight’s path to regulatory clearance and adoption of its transformative technology, the company says in a press release. The release adds that AngioInsight is focused on bringing precision to the assessment and diagnosis of cardiovascular disease and, importantly, coronary microvascular disease, which is difficult to diagnose, especially in women.
“We are excited to launch this pivotal clinical study for AngioInsight,” said Scott Burger, CEO of AngioInsight. “This study aims to validate the robustness of our AI-powered platform using data from real-world clinical settings. By harnessing AI’s power, the AngioAI+ platform will equip cardiologists with rapid and enhanced cardiovascular diagnostic capabilities, as well as identifying patients with CMD, with the goal of improving patient care outcomes.”
Slated to begin in mid 2025, the study will enrol patients suspected of coronary artery disease (CAD) undergoing coronary angiography and clinically indicated coronary physiologic assessment in the cardiac cath lab.
The primary objective is to evaluate the diagnostic performance of the AngioAI+ platform in providing estimated FFR and the detection of CMD. Current detection methods for CMD involve invasive wires with added challenge and patient risk, and advanced tests for the non-invasive assessment of CMD are often not available, expensive, and (in the case of positron emission tomography) require radiation.
The AngioAI+ platform is being designed to provide an accurate assessment of CMD, non-invasively within minutes.
The study will be led by Todd C Villines (University of Virginia, Charlottesville, USA) and Carlos Collet (OLV Hospital, Aalst, Belgium). The trial will be conducted across 15 centres in the USA and Europe. Upon completion, AngioInsight plans to submit the results to regulatory authorities for review and marketing authorisation, advancing the pathway for commercialisation and widespread use.
