NCT01268319

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

A Randomized Pilot Trial of the Use of a Distal Protection Device to Prevent Peri-procedural MI During Dilation of Coronary Stenoses Caused by Plaques With Large Lipid Cores

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Infraredx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Atherosclerosis
• Myocardial Infarction
• Coronary Plaque Embolization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• Completion: 2016-11-01
• First posted: 2010-12-30
• Last updated: 2017-06-12

Locations

9 sites across 1 country: United States