CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
NCT ID: NCT01268319
Last Updated: 2017-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
85 participants
INTERVENTIONAL
2011-05-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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(+)HR-LCP and EPD
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.
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.
(+)HR-LCP and No EPD (standard of care)
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.
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.
(-)HR-LCP and No EPD (standard of care)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Infraredx
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg W. Stone, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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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
Countries
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Other Identifiers
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0114
Identifier Type: -
Identifier Source: org_study_id
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