The CANARY (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow) Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is at high risk of rupturing during standard of care therapy and causing intra-procedural complications. If plaques that require treatment are at higher than normal risk of causing intra-procedural complications, some life threatening, the treating physician is better informed and may opt to take precautionary measures to mitigate the risk or result of a complication. The CANARY Study is also designed to evaluate the feasibility of using a distal embolization protection device (EPD) as a means to prevent heart attacks triggered by the embolization of plaque during standard care therapy. It is thought that the EPD will prevent plaque from going downstream during treatment and obstructing other heart vessels. These obstructions could cause heart attacks by preventing blood from reaching heart muscle tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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.
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.
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.
Scottsdale Healthcare Shea
Scottsdale, Arizona, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Spectrum Health System
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mount Sinai School of Medicine Hospital
New York, New York, United States
Pinnacle Health Cardiovascular Insititute
Harrisburg, Pennsylvania, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, United States
Veterans Affairs North Texas Health Care Systems
Dallas, Texas, United States
Evidence of Peri-procedural Myocardial Infarction as the result of standard care stenting procedure.
The occurrence of a peri-procedural MI in the context of the CANARY trial will be defined as an elevation of troponin I (cTnI), or troponin T (cTnT) above three times the upper limit of normal (\>3xULN).
Time frame: <24 hours after percutaneous coronary intervention
Evidence of Peri-procedural Myocardial Infarction as the result of standard
The occurrence of a peri-procedural MI in the context of the CANARY trial will be defined as an elevation of creatine kinase myocardial band (CK-MB) biomarker above three times the upper limit of normal (\>3xULN).
Time frame: <24 hours after percutaneous coronary intervention
Frequency of Intraprocedural complications related to the treatment of the Target Plaque.
Instances of TIMI flow degradation, Procedural Success, Dissection/Perforations, abrupt closure, thrombus generation, etc will be recorded to determine the any gross differences in event rates between the study groups.
Time frame: Catheterization Start Time to Completion Time.
Composite MACE
The composite major adverse cardiac event rate (death, myocardial infarction, revascularization of the target lesion or vessel, cerebral vascualar accident will be reported for all groups at 30 days from the initial treatment (+/- 7 days).
Time frame: from discharge from initial hospital stay to 30 (+/-7days) following the procedure
Composite MACE
The composite major adverse cardiac event rate (death, myocardial infarction, revascularization of the target lesion or vessel, cerebral vascualar accident will be reported for all groups at 365 days from the initial treatment (+/- 30 days).
Time frame: 365 days (+/- 30days) from initial procedure
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