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

NCT01268319 | Terminated DMC

• 1 other identifier: 0114
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronary Atherosclerosis; Myocardial Infarction; Coronary Plaque Embolization

Keywords

Myocardial Infarction; percutaneous coronary intervention; embolization; necrotic core; vulnerable plaque; coronary plaque rupture

Outcome Measures

Primary Outcomes (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).

  <24 hours after percutaneous coronary intervention

Secondary Outcomes (4)

• Evidence of Peri-procedural Myocardial Infarction as the result of standard

  <24 hours after percutaneous coronary intervention

• Frequency of Intraprocedural complications related to the treatment of the Target Plaque.

  Catheterization Start Time to Completion Time.

• Composite MACE

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

• Composite MACE

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

Study Arms (3)

(+)HR-LCP and EPD

EXPERIMENTAL

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); Device: Intracoronary Spectroscopy and Ultrasonic Evaluation; Device: Angioplasty and Stent Implant

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

PLACEBO COMPARATOR

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; Device: Angioplasty and Stent Implant

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

PLACEBO COMPARATOR

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; Device: Angioplasty and Stent Implant

Interventions

Embolic Protection Device (EPD) DEVICE

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.

Also known as: Filterwire

(+)HR-LCP and EPD

Intracoronary Spectroscopy and Ultrasonic Evaluation DEVICE

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.

Also known as: LipiScan IVUS Coronary Imaging System, LipiScan IVUS, LipiScan, Chemogram

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

Angioplasty and Stent Implant DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Infraredx: lead

Study Sites (9)

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85258, United States

Location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mount Sinai School of Medicine Hospital

New York, New York, 10029, United States

Location

Pinnacle Health Cardiovascular Insititute

Harrisburg, Pennsylvania, 17101, United States

Location

Medical University of South Carolina Hospital

Charleston, South Carolina, 29403, United States

Location

Veterans Affairs North Texas Health Care Systems

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Embolic Protection Devices; Angioplasty; Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Gregg W. Stone, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 30, 2010
• Study Start: May 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2016
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

US (9)