InfraReDx Initiates CANARY Trial With LipiScan IVUS System

July 13, 2011—InfraReDx, Inc. (Burlington, MA) announced commencement of the CANARY (Coronary Assessment by Near-Infrared [NIR] of Atherosclerotic Rupture-Prone Yellow) clinical trial with the enrollment of the first patient. Gregg W. Stone, MD, is Principal Investigator of the trial.

The company stated that the phase 2 CANARY trial is designed to test the hypothesis that NIR-guided use of an embolic protection device during percutaneous coronary intervention can reduce the rate of periprocedural myocardial infarction (MI) in patients identified as having high-risk lipid core plaques (HR-LCPs). CANARY is a prospective, multicenter, randomized, open-label trial expected to enroll 108 patients at 10 clinical sites in the United States. Patients identified as having an HR-LCP are randomized 1:1 to standard treatment (angioplasty and stent implantation) or standard treatment plus the use of a filter designed to prevent embolization. Patients whose target lesion does not contain HR-LCP are assigned to standard therapy; these patients are not randomized.

The primary efficacy endpoint in the study is reduction in periprocedural MI, which is defined as an elevation of cardiac biomarkers. The primary safety endpoint is the occurrence of adverse events collected between discharge and 1 year postprocedure.

The study will use InfraReDx's LipiScan intravenous ultrasound (IVUS) coronary imaging system, which received US Food and Drug Administration approval in June 2010, and CE Mark approval for marketing in Europe in April 2011. Boston Scientific Corporation (Natick, MA) is providing the FilterWire EZ embolic protection system for the study.

According to InfraReDx, the LipiScan system includes a cardiac catheter that combines IVUS and NIR spectroscopy to aid in identifying and characterizing LCPs, which are known to complicate stenting and suspected to cause most MIs. In a single catheter pullback, the system provides a traditional IVUS image that clearly displays key structural parameters of the lesion, including its location, length, degree of stenosis, and plaque burden in addition to confirming proper stent placement. At the same time, the system performs spectroscopic analysis of optical data to produce a chemogram map that indicates the location of LCPs and quantifies their lipid core burden. Integrating and coregistering the chemogram with IVUS provides immediate and valuable information to interventional cardiologists during the cardiac catheterization procedure.