85
Participants
Start Date
May 31, 2011
Primary Completion Date
September 30, 2014
Study Completion Date
November 30, 2016
Embolic Protection Device (EPD)
"The embolic protection device consists of a protection wire, a delivery sheath, a retrieval sheath and various accessories (wire torque device, introducer, dilator tool). The wire of the EPD is used as a standard 0.014 steerable guide wire. The filter is designed for embolic debris capture while maintaining continuous blood flow. At the completion of the procedure, the filter and its contents are removed using the retrieval sheath and then removed from the patient."
Intracoronary Spectroscopy and Ultrasonic Evaluation
This intervention requires a near infrared imaging catheter equipped with an intravascular ultrasonic transducer be used to evaluate the coronary artery wall prior to treatment and after treatment. This system detects the lipid containing plaques that may be the source of embolic debris released during standard angioplasty and stent placement.
Angioplasty and Stent Implant
The target plaque will be treated with a pre-dilation with a standard angioplasty balloon sized to within 0.5mm of the diameter of the reference vessel diameter. The physician will then implant a coronary artery stent that is appropriately sized for the reference vessel diameter.
Mount Sinai School of Medicine Hospital, New York
Pinnacle Health Cardiovascular Insititute, Harrisburg
Washington Hospital Center, Washington D.C.
Medical University of South Carolina Hospital, Charleston
William Beaumont Hospital, Royal Oak
Spectrum Health System, Grand Rapids
Veterans Affairs North Texas Health Care Systems, Dallas
Scottsdale Healthcare Shea, Scottsdale
San Francisco Veterans Affairs Medical Center, San Francisco
Lead Sponsor
Infraredx
INDUSTRY