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Coronary AtherosclerosisCANARYNCT01268319

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

A study testing Embolic Protection Device (EPD), Intracoronary Spectroscopy and Ultrasonic Evaluation and Angioplasty and Stent Implant in people with Coronary Atherosclerosis and Myocardial Infarction, run by Infraredx at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Embolic Protection Device (EPD), Intracoronary Spectroscopy and Ultrasonic Evaluation and Angioplasty and Stent Implant
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
9 sitesUnited States
Study dates
May 2011to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Medical University of South Carolina Hospital

    Charleston, South Carolina, 29403

  • Veterans Affairs North Texas Health Care Systems

    Dallas, Texas, 75216

  • Spectrum Health System

    Grand Rapids, Michigan, 49503

  • Pinnacle Health Cardiovascular Insititute

    Harrisburg, Pennsylvania, 17101

  • Mount Sinai School of Medicine Hospital

    New York, New York, 10029

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85258

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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.

Being tested
Embolic Protection Device (EPD), Intracoronary Spectroscopy and Ultrasonic Evaluation, Angioplasty and Stent Implant
Keywords
Myocardial Infarction, percutaneous coronary intervention, embolization, necrotic core, vulnerable plaque, coronary plaque rupture
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Embolic Protection Device (EPD)Device

    Also called Filterwire

    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 EvaluationDevice

    Also called LipiScan IVUS Coronary Imaging System, LipiScan IVUS, LipiScan, Chemogram

    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 ImplantDevice

    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.

Study groups in NCT01268319
Study groupRoleWhat they receive
(+)HR-LCP and EPDExperimentalThese 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.
Receives: 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 comparatorThese 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.
Receives: Device: Intracoronary Spectroscopy and Ultrasonic Evaluation; Device: Angioplasty and Stent Implant
(-)HR-LCP and No EPD (standard of care)Placebo comparatorThese 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.
Receives: Device: Intracoronary Spectroscopy and Ultrasonic Evaluation; Device: Angioplasty and Stent Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: <24 hours after percutaneous coronary intervention

Secondary outcomes (4)

  1. 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).

    Measured: <24 hours after percutaneous coronary intervention

  2. 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.

    Measured: Catheterization Start Time to Completion Time.

  3. 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).

    Measured: from discharge from initial hospital stay to 30 (+/-7days) following the procedure

  4. 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).

    Measured: 365 days (+/- 30days) from initial procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2010 (estimated)
  2. Study startMay 2011
  3. Primary completionSep 2014
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01268319
Sponsor's protocol ID
0114
Acronym
CANARY
Status last verified
Jun 2017
First submitted
28 Dec 2010
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Embolic Protection Device (EPD), Intracoronary Spectroscopy and Ultrasonic Evaluation and Angioplasty and Stent Implant in people with Coronary Atherosclerosis and Myocardial Infarction, run by Infraredx at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Peri-procedural Myocardial Infarction as the result of standard care stenting procedure. (time frame: <24 hours after percutaneous coronary intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01268319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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