Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Infraredx
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Target lesion is excessively calcified
Clareo Health | CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
