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

Infraredx

Status: Terminated

Conditions: Coronary Atherosclerosis; Myocardial Infarction; Coronary Plaque Embolization

Treatments: Device: Intracoronary Spectroscopy and Ultrasonic Evaluation; Device: Embolic Protection Device (EPD); Device: Angioplasty and Stent Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268319

0114

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subject is at least 18 years of age
• Subject is scheduled for an elective coronary catheterization
• Subject is willing and able to provide informed written consent prior to the index catheterization
• LipiScan IVUS CIS use is not contra-indicated
• At least one submitted Chemogram is obtained entirely within a native coronary artery
• Patient has been diagnosed with: stable angina (CCS I or CCS II);a positive functional test for ischemia (within the preceding 30 days); OR Stabilized acute coronary syndrome (unstable angina (CCS III, or CCS IV), non STEMI, or STEMI with no chest pain or other cardiac symptoms for >24 hours
• Blood cardiac biomarker (i.e. troponin I, CK-MB) levels less than the local laboratory ULN within 12 hours of the time of PCI guidewire placement.
• Subject is to undergo PCI of a single lesion in a single native coronary artery during the enrollment procedure.
• There is prior intent to treat the target lesion as part of the patient's clinical care.
• The target lesion angiographic stenosis visually estimated as >=50% and <100%
• The target lesion reference vessel diameter must be >=2.5mm (visually estimated)
• Total target lesion length must be ≤60 mm (visually estimated)
• The minimum landing zone requirements for the FilterWire device can be met.
• There must be no major side branches (>2.0 mm in diameter) within the target lesion.
• There must be no major side branches (>2.0mm in diameter) between the target lesion and the filter nitinol loop landing zone.

Exclusion Criteria

• Subject is currently, or within the preceding 30 days, participating in a device or pharmaceutical treatment protocol.
• Subject life expectancy at time of enrollment is less than 2 years;
• Subject is pregnant or suspected to be pregnant at time of enrollment
• Prior coronary bypass graft surgery (CABG)
• PCI performed within the 24hours prior to the start of the study procedure
• A PCI is planned within the 30 days following the enrollment procedure.
• Unable to take aspirin and a thienopyridine for at least 30 days
• Patient experienced a STEMI or non STEMI within the past 24 hours
• Documented LVEF <25%
• the patient has multi-lesion or multi-vessel disease requiring revascularization of multiple lesions during the enrollment catheterization
• Any angiographic evidence of thrombus in any coronary artery
• There is evidence of dissection or procedural complication prior to randomization
• Patient has unprotected left main (≥50% stenosis) or left main equivalent disease
• Target Lesion is located in the distal segment of the target native coronary artery
• Proximal bound of the target lesion is located within 3mm of the ostium of the target vessel or major side branch (>2mm diameter by visual estimate)
• Target lesion is excessively calcified

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups, including a placebo group

(+)HR-LCP and EPD

Experimental group

Description:

These subjects will meet all angiographic criteria.The target plaque will contain a LipiScan IVUS signal that meets the Higher Risk Lipid Core Plaque (HR-LCP) definition contained in the protocol. 27 Subjects who meet this criteria will be randomized to standard pre-dilation and stent implantation with an embolic protection device (EPD)in place prior to any angioplasty.

Treatment:

Device: Embolic Protection Device (EPD)

Device: Intracoronary Spectroscopy and Ultrasonic Evaluation

Device: Angioplasty and Stent Implant

(+)HR-LCP and No EPD (standard of care)

Placebo Comparator group

Description:

These subjects will meet all angiographic criteria.The target plaque will contain a LipiScan IVUS signal that meets the Higher Risk Lipid Core Plaque (HR-LCP) definition contained in the protocol. 27 Subjects who meet this criteria will be randomized to standard pre-dilation and stent implantation without an embolic protection device (EPD)in place prior to any angioplasty.

Treatment:

Device: Intracoronary Spectroscopy and Ultrasonic Evaluation

Device: Angioplasty and Stent Implant

(-)HR-LCP and No EPD (standard of care)

Placebo Comparator group

Description:

These subjects will meet all angiographic criteria.The target plaque will NOT contain a LipiScan IVUS signal that meets the Higher Risk Lipid Core Plaque (HR-LCP) definition contained in the protocol. 54 Subjects who meet this criteria will be assigned (not randomized) to standard pre-dilation and stent implantation without an embolic protection device (EPD)in place prior to any angioplasty.

Treatment:

Device: Intracoronary Spectroscopy and Ultrasonic Evaluation

Device: Angioplasty and Stent Implant