Back to resultsCANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow (CANARY)
Primary Purpose
Coronary Atherosclerosis, Myocardial Infarction, Coronary Plaque Embolization
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embolic Protection Device (EPD)
Intracoronary Spectroscopy and Ultrasonic Evaluation
Angioplasty and Stent Implant
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Myocardial Infarction, percutaneous coronary intervention, embolization, necrotic core, vulnerable plaque, coronary plaque rupture
Eligibility 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
Sites / Locations
- Scottsdale Healthcare Shea
- San Francisco Veterans Affairs Medical Center
- Washington Hospital Center
- Spectrum Health System
- William Beaumont Hospital
- Mount Sinai School of Medicine Hospital
- Pinnacle Health Cardiovascular Insititute
- Medical University of South Carolina Hospital
- Veterans Affairs North Texas Health Care Systems
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
(+)HR-LCP and EPD
(+)HR-LCP and No EPD (standard of care)
(-)HR-LCP and No EPD (standard of care)
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01268319
Brief Title
CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
Acronym
CANARY
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
May 2011 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infraredx
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis, Myocardial Infarction, Coronary Plaque Embolization
Keywords
Myocardial Infarction, percutaneous coronary intervention, embolization, necrotic core, vulnerable plaque, coronary plaque rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(+)HR-LCP and EPD
Arm Type
Experimental
Arm 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.
Arm Title
(+)HR-LCP and No EPD (standard of care)
Arm Type
Placebo Comparator
Arm 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.
Arm Title
(-)HR-LCP and No EPD (standard of care)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Embolic Protection Device (EPD)
Other Intervention Name(s)
Filterwire
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intracoronary Spectroscopy and Ultrasonic Evaluation
Other Intervention Name(s)
LipiScan IVUS Coronary Imaging System, LipiScan IVUS, LipiScan, Chemogram
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Angioplasty and Stent Implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of Peri-procedural Myocardial Infarction as the result of standard care stenting procedure.
Description
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
Secondary Outcome Measure Information:
Title
Evidence of Peri-procedural Myocardial Infarction as the result of standard
Description
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
Title
Frequency of Intraprocedural complications related to the treatment of the Target Plaque.
Description
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.
Title
Composite MACE
Description
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
Title
Composite MACE
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg W. Stone, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scottsdale Healthcare Shea
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Spectrum Health System
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mount Sinai School of Medicine Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pinnacle Health Cardiovascular Insititute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Medical University of South Carolina Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Veterans Affairs North Texas Health Care Systems
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
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