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

June 8, 2017 updated by: Infraredx

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare Shea
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health System
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Health Cardiovascular Insititute
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Veterans Affairs North Texas Health Care Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: (+)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.
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.
Other Names:
  • Filterwire
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.
Other Names:
  • LipiScan IVUS Coronary Imaging System
  • LipiScan IVUS
  • LipiScan
  • Chemogram
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.
Placebo Comparator: (+)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.
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.
Other Names:
  • LipiScan IVUS Coronary Imaging System
  • LipiScan IVUS
  • LipiScan
  • Chemogram
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.
Placebo Comparator: (-)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.
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.
Other Names:
  • LipiScan IVUS Coronary Imaging System
  • LipiScan IVUS
  • LipiScan
  • Chemogram
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evidence of Peri-procedural Myocardial Infarction as the result of standard care stenting procedure.
Time Frame: <24 hours after percutaneous coronary intervention
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).
<24 hours after percutaneous coronary intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evidence of Peri-procedural Myocardial Infarction as the result of standard
Time Frame: <24 hours after percutaneous coronary intervention
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).
<24 hours after percutaneous coronary intervention
Frequency of Intraprocedural complications related to the treatment of the Target Plaque.
Time Frame: Catheterization Start Time to Completion Time.
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.
Catheterization Start Time to Completion Time.
Composite MACE
Time Frame: from discharge from initial hospital stay to 30 (+/-7days) following the procedure
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).
from discharge from initial hospital stay to 30 (+/-7days) following the procedure
Composite MACE
Time Frame: 365 days (+/- 30days) from initial procedure
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).
365 days (+/- 30days) from initial procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Infraredx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregg W. Stone, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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