1. The patient is pregnant or breastfeeding. 
2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery. 
3. Cardiogenic shock on presentation or during current hospitalization. 
4. Left ventricular ejection fraction less than 20%. 
5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated). 
6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3. 
7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L). 
8. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials). 
9. Prior participation in this study. 
10. Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients. 
11. Stroke or transient ischemic attack within the prior 3 months. 
12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months. 
13. Subject has active sepsis. 
14. Unprotected left main coronary artery disease (stenosis greater than 50%). 
15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study. 
16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis). 
17. Any target vessel has evidence of: 
excessive thrombus (e.g. requires target vessel thrombectomy) 
tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment, 
heavy calcification. 
18. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). 
19. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible. 
20. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).       
    

NCT01116882_exc_T1
Condition
pregnant
NCT01116882_exc_T2
Observation
breastfeeding
NCT01116882_exc_T3
Condition
STEMI
NCT01116882_exc_T4
Temporal
within 72 hours
NCT01116882_exc_T5
Qualifier
infarct related artery
NCT01116882_exc_T6
Qualifier
non-infarct related artery
NCT01116882_exc_T7
Procedure
treatment
NCT01116882_exc_T8
Scope
infarct related or non-infarct related artery
NCT01116882_exc_T9
Condition
Cardiogenic shock
NCT01116882_exc_T10
Procedure
hospitalization
NCT01116882_exc_T11
Temporal
current
NCT01116882_exc_T12
Measurement
Left ventricular ejection fraction
NCT01116882_exc_T13
Value
less than 20%
NCT01116882_exc_T14
Drug
aspirin
NCT01116882_exc_T15
Drug
clopidogrel
NCT01116882_exc_T16
Drug
Plavix
NCT01116882_exc_T17
Drug
ticlopidine
NCT01116882_exc_T18
Drug
Ticlid
NCT01116882_exc_T19
Drug
heparin
NCT01116882_exc_T20
Drug
bivalirudin
NCT01116882_exc_T21
Observation
stainless steel
NCT01116882_exc_T22
Drug
contrast agent
NCT01116882_exc_T23
Condition
allergies
NCT01116882_exc_T24
Scope
aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent
NCT01116882_exc_T25
Measurement
platelet count
NCT01116882_exc_T26
Value
less than 75,000 cells/mm3
NCT01116882_exc_T27
Value
greater than 700,000 cells/mm3
NCT01116882_exc_T28
Measurement
WBC
NCT01116882_exc_T29
Value
less than 3,000 cells/mm3
NCT01116882_exc_T30
Scope
less than 75,000 cells/mm3 or greater than 700,000 cells/mm3
NCT01116882_exc_T31
Condition
chronic renal dysfunction
NCT01116882_exc_T32
Condition
Acute renal dysfunction
NCT01116882_exc_T33
Measurement
creatinine
NCT01116882_exc_T34
Value
greater than 2.5 mg/dl
NCT01116882_exc_T35
Value
less than 150µmol/L
NCT01116882_exc_T36
Scope
greater than 2.5 mg/dl or less than 150µmol/L
NCT01116882_exc_T40
Temporal
Within 30 days prior to the index study procedure
NCT01116882_exc_T41
Reference_point
the index study procedure
NCT01116882_exc_T42
Procedure
coronary interventional procedure
NCT01116882_exc_T43
Temporal
previous
NCT01116882_exc_T45
Condition
STEMI
NCT01116882_exc_T44
Condition
Stroke
NCT01116882_exc_T46
Condition
transient ischemic attack
NCT01116882_exc_T47
Negation
not
NCT01116882_exc_T48
Temporal
within the prior 3 months
NCT01116882_exc_T49
Scope
Stroke or transient ischemic attack
NCT01116882_exc_T50
Condition
peptic ulcer
NCT01116882_exc_T51
Temporal
Active
NCT01116882_exc_T52
Condition
upper gastrointestinal bleeding
NCT01116882_exc_T53
Temporal
within the prior 3 months
NCT01116882_exc_T54
Scope
peptic ulcer or upper gastrointestinal bleeding
NCT01116882_exc_T55
Condition
sepsis
NCT01116882_exc_T56
Temporal
active
NCT01116882_exc_T57
Condition
left main coronary artery disease
NCT01116882_exc_T58
Qualifier
Unprotected
NCT01116882_exc_T59
Measurement
stenosis
NCT01116882_exc_T60
Condition
stenosis
NCT01116882_exc_T61
Value
greater than 50%
NCT01116882_exc_T63
Measurement
life expectancy
NCT01116882_exc_T64
Observation
life expectancy
NCT01116882_exc_T65
Value
less than one year
NCT01116882_exc_T67
Condition
coronary lesion
NCT01116882_exc_T68
Measurement
coronary lesion
NCT01116882_exc_T69
Value
less than 50% stenosis
NCT01116882_exc_T70
Condition
stenosis
NCT01116882_exc_T71
Condition
thrombus
NCT01116882_exc_T72
Procedure
target vessel thrombectomy
NCT01116882_exc_T73
Condition
tortuousity
NCT01116882_exc_T74
Value
greater than 60 degree
NCT01116882_exc_T75
Measurement
angle
NCT01116882_exc_T76
Procedure
stent delivery and deployment
NCT01116882_exc_T77
Qualifier
unsuitable for proper
NCT01116882_exc_T79
Condition
calcification
NCT01116882_exc_T80
Qualifier
heavy
NCT01116882_exc_T81
Device
device other than percutaneous transluminal coronary angioplasty (PTCA)
NCT01116882_exc_T82
Procedure
percutaneous transluminal coronary angioplasty (PTCA)
NCT01116882_exc_T83
Negation
other than
NCT01116882_exc_T84
Procedure
stent placement
NCT01116882_exc_T85
Temporal
prior to stent placement
NCT01116882_exc_T86
Reference_point
stent placement
NCT01116882_exc_T87
Procedure
directional coronary atherectomy
NCT01116882_exc_T88
Procedure
excimer laser
NCT01116882_exc_T89
Procedure
rotational atherectomy
NCT01116882_exc_T90
Scope
directional coronary atherectomy, excimer laser, rotational atherectomy
NCT01116882_exc_T91
Mood
requires
NCT01116882_exc_T92
Procedure
treatment
NCT01116882_exc_T93
Condition
target lesion
NCT01116882_exc_T94
Device
saphenous vein graft
NCT01116882_exc_T95
Condition
lesion
NCT01116882_exc_T96
Qualifier
located in a saphenous vein graft
NCT01116882_exc_T97
Qualifier
within the native vessel
NCT01116882_exc_T99
Qualifier
accessed through the graft
NCT01116882_exc_T100
Scope
within the native vessel but accessed through the graft