CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow

NATerminatedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

November 30, 2016

Conditions
Coronary AtherosclerosisMyocardial InfarctionCoronary Plaque Embolization
Interventions
DEVICE

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."

DEVICE

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.

DEVICE

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.

Trial Locations (9)

10029

Mount Sinai School of Medicine Hospital, New York

17101

Pinnacle Health Cardiovascular Insititute, Harrisburg

20010

Washington Hospital Center, Washington D.C.

29403

Medical University of South Carolina Hospital, Charleston

48073

William Beaumont Hospital, Royal Oak

49503

Spectrum Health System, Grand Rapids

75216

Veterans Affairs North Texas Health Care Systems, Dallas

85258

Scottsdale Healthcare Shea, Scottsdale

94121

San Francisco Veterans Affairs Medical Center, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Infraredx

INDUSTRY