Coronary Assessment by Near infrared of Atherosclerotic Rupture-prone Yellow [CANARY Trial]
ID Number 11-1429Principal Investigator(s)
Annapoorna S Kini
Department(s) or Division(s)
The Zena and Michael A. Wiener Cardiovascular Institute
The purpose of the study is to test the use of an investigational device, called an embolic protection device (EPD-Filterwire EZ), that removes the debris in the blood vessel during a procedure called Percutaneous Coronary Intervention (PCI). During PCI, a metal mesh tube is used to open the blood vessel of the heart of patients with hardening of the blood vessels of the heart due to a large amount of fat in the blood vessel wall. This can be seen by a primary care doctor using a machine called LipiScan IVUS. The LipiScan IVUS is a machine that determines the amount of fat in the walls of the blood vessel of the heart and displays the image of the blood vessels of the heart including the plaque. The LipiScan IVUS produces a map that determines the location of the fat in the walls of the blood vessels of the heart. This study would like to test if the investigational device (EPD-Filterwire EZ), can reduce the rate of heart attacks during and after PCI.
The investigational device, (EPD-Filterwire EZ), is approved by the FDA to be used on patients who will undergo coronary bypass surgery. The device is approved to be used on bypass grafts but not for the blood vessels in the heart.
The research study is expected to last for one year. Participants will be contacted by telephone at 30-day, 6-month and 1-year regarding overall health, major events and other hospitalization.
A total 108 patients will be enrolled in 10 centers.
The total number of people expected to take part in this research study at Mount Sinai site is 30.
Kristin Falciglia, CRC
Recruiting Patients: Yes