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

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