Clinical trial NCT01268319: CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
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
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Atherosclerosis
Myocardial Infarction
Coronary Plaque Embolization
Keywords: Myocardial Infarction
percutaneous coronary intervention
embolization
necrotic core
vulnerable plaque
coronary plaque rupture
Lead sponsor: Infraredx
Sponsor class: INDUSTRY
First posted: 2010-12-30
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evidence of Peri-procedural Myocardial Infarction as the result of standard care stenting procedure.
timeFrame: <24 hours after percutaneous coronary intervention
Secondary outcomes:
measure: Evidence of Peri-procedural Myocardial Infarction as the result of standard
timeFrame: <24 hours after percutaneous coronary intervention
measure: Frequency of Intraprocedural complications related to the treatment of the Target Plaque.
timeFrame: Catheterization Start Time to Completion Time.
measure: Composite MACE
timeFrame: from discharge from initial hospital stay to 30 (+/-7days) following the procedure
measure: Composite MACE
timeFrame: 365 days (+/- 30days) from initial procedure
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Shea
state: Arizona
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: Mount Sinai School of Medicine Hospital
state: New York
city: Harrisburg
country: United States
facility: Pinnacle Health Cardiovascular Insititute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Dallas
country: United States
facility: Veterans Affairs North Texas Health Care Systems
state: Texas
Study officials:
affiliation: Columbia University
name: Gregg W. Stone, M.D.
role: PRINCIPAL_INVESTIGATOR
References: