InfraReDx has started a Phase 2 clinical trial - coronary assessment by near-infrared (nir) of atherosclerotic rupture-prone yellow (CANARY) - in patients with high-risk lipid core plaques (HR-LCPs).
CANARY is a multicenter, open-label, prospective, randomized trial will enroll 108 patients at 10 clinical sites in the US.
The study is designed to assess the possibility that LipiScan IVUS Coronary Imaging System-Guided use of an embolic protection device (EPD), or filter can reduce the rate of peri-procedural heart attacks.
The system comprises cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to aid cardiologists to identify and characterize lipid core coronary plaques.
The primary efficacy endpoint in the study is reduction in peri-procedural MI, an elevation of cardiac biomarkers.
Boston Scientific is also providing the FilterWire EZ Embolic Protection System for the study.
InfraReDx chairman, founder and CMO James Muller said they are pleased to initiate this randomized trial testing the diagnostic capabilities of LipiScan IVUS to guide use of a treatment capable of preventing embolic infarction.