InfraReDx announced enrolment of the first patient in its phase II clinical trial, CANARY (Coronary assessment by near-infrared (NIR) of atherosclerotic rupture-prone yellow). CANARY is designed to test the hypothesis that NIR-guided use of an embolic protection device, or filter, during percutaneous coronary intervention can reduce the rate of peri-procedural heart attacks in patients identified as having high-risk lipid core plaques.
InfraReDx’s LipiScan IVUS system is the only multimodality coronary imaging device approved in both the USA and Europe. It is in routine clinical use to detect the lipid core plaques known to complicate stenting and suspected to cause most heart attacks.
CANARY is a prospective, multicentre, randomised, open-label phase II trial expected to enrol 108 patients at 10 clinical sites in the USA. Patients identified as having a high-risk lipid core plaque are randomised 1:1 to standard treatment (angioplasty and stent implantation) or standard treatment plus the use of a filter designed to prevent embolization. Subjects whose target lesion does not contain high risk lipid core plaques are assigned to standard therapy; these subjects are not randomised.
The primary efficacy endpoint in the study is reduction in peri-procedural myocardial infarction, which is defined as an elevation of cardiac biomarkers. The primary safety endpoint is the occurrence of adverse events collected between discharge and one year post-procedure.
“We will test the hypothesis that LipiScan IVUS, by detecting large lipid core plaques that are prone to embolization when dilated, can identify the subset of coronary patients in which a device designed to prevent distal embolization will be effective,” said Gregg W Stone, professor of medicine, director of cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, USA, and principal investigator of CANARY. “A positive result of CANARY will be a step forward in efforts to enhance the safety of coronary stenting.”
Multiple studies indicate that approximately 10% of patients undergoing percutaneous coronary intervention experience a heart attack during the stenting procedure. There is considerable clinical evidence indicating that such heart attacks are caused by disruption by balloon dilation of large lipid core plaques. The contents of these plaques are then carried downstream and occlude the small coronary arteries. LipiScan IVUS can detect the large lipid core plaques most likely to cause this problem, and thereby identify cases in which a distal protection filter might be most effective.
Boston Scientific is providing the FilterWire EZ embolic protection system for the study.
About the LipiScan IVUS coronary imaging system
The LipiScan IVUS coronary imaging system received FDA approval in June 2010 and CE mark in April 2011. The system includes the world’s first and only cardiac catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to help cardiologists identify and characterise lipid core coronary plaques.
In a single catheter pullback, the LipiScan IVUS provides physicians with 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 lipid core plaques and quantifies their lipid core burden.
Integrating and co-registering the Chemogram with IVUS provides immediate and valuable information to interventional cardiologists during the cardiac catheterisation procedure.