Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
1. patient is ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Patient eligible Percutaneous Coronary Intervention
Item
2. patient is eligible for percutaneous coronary intervention (pci)
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
3. patient demonstrates a left ventricular ejection fraction (lvef) of ≥ 25%
boolean
C0428772 (UMLS CUI [1])
Protocol Compliance | Protocol Compliance Legal Guardian | Informed Consent | Informed Consent Legal Guardian
Item
4. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0023226 (UMLS CUI [4,2])
Inclusion criteria Angiography
Item
angiographic inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Target Lesion Identification | Lesion de novo Coronary artery Native | Lesion size | Therapeutic procedure Stent Single
Item
1. target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated) ≤ 25 mm that can be treated with a single jactax, jactax ld or taxus stent
boolean
C2986546 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0205042 (UMLS CUI [2,3])
C0302891 (UMLS CUI [2,4])
C0449453 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0038257 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Lesion second Vessel second | Therapeutic procedure Drug-Eluting Stent Single | Therapeutic procedure Bare metal stent Single
Item
2. a second lesion in a second vessel may be treated with one (1) taxus™ libertè™ des or a bare metal stent.
boolean
C0221198 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0205436 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C2825200 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
Exclusion Criteria General
Item
general exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Life Expectancy Due to Other medical condition
Item
1. the patient has a life expectancy of less than 24 months due to another medical condition
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Paclitaxel allergy | Hypersensitivity Compound Similar
Item
2. patient has a history of hypersensitivity to paclitaxel or structurally related compounds
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
Shock, Cardiogenic | Systolic Pressure | Pulmonary Capillary Wedge Pressure | Cardiac index | Intra-aortic balloon pump | Inotropic agent Intravenous
Item
3. patient exhibits cardiogenic shock (systolic pressure < 80mm hg and pcwp > 20mm hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm hg) for any time within 24 hours prior to index procedure
boolean
C0036980 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0086879 (UMLS CUI [3])
C0428776 (UMLS CUI [4])
C0702122 (UMLS CUI [5])
C0304509 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum
Item
4. patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or177 µmol/l)
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Cardiac Surgery procedure Planned
Item
5. planned cardiac surgery procedure ≤ 6 months post-index procedure
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Myocardial Infarction | STEMI | Elevated creatine kinase | Creatine kinase MB measurement | Cerebrovascular accident | Transient Ischemic Attack
Item
6. patient demonstrates evidence of a acute myocardial infarction (eg. stemi or enzyme elevation ck > 2x local laboratory's uln unless ck-mb is < 2x uln) 7) cerebrovascular accident (cva) including stroke or tia within previous 3 months
boolean
C0027051 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
C0523584 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Leukopenia | White Blood Cell Count procedure
Item
7. patient demonstrates evidence of leukopenia (leukocyte count < 3.5 x 109/liter)
boolean
C0023530 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement | Thrombocytosis
Item
8. patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0836924 (UMLS CUI [3])
Medical contraindication Aspirin | Exception Desensitization Successful Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine
Item
9. patient is contraindicated to asa (successful prior desensitization to asa is not an exclusion), clopidogrel, or ticlopidine
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0178702 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
Warfarin | Warfarin Possibly
Item
10. patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
boolean
C0043031 (UMLS CUI [1])
C0043031 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Paclitaxel | Chemotherapeutic Agents
Item
11. patient has been treated with paclitaxel or other chemotherapeutic agents within 12-months prior to planned index procedure
boolean
C0144576 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Paclitaxel | Rapamycin Oral
Item
12. anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
boolean
C0144576 (UMLS CUI [1])
C0072980 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Drug-Eluting Stent Implantation
Item
13. patient has received a drug eluting stent within 12-months prior to planned index procedure
boolean
C1322815 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Intravascular brachytherapy Target vessel | Intravascular brachytherapy Planned Target vessel
Item
14. previous or planned treatment with intravascular brachytherapy in target vessel
boolean
C0994608 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C0994608 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0449618 (UMLS CUI [2,3])
Hypersensitivity Stainless Steel
Item
15. known allergy to stainless steel
boolean
C0020517 (UMLS CUI [1,1])
C0038126 (UMLS CUI [1,2])
Intention Reproduction | Relationship Exposure to Paclitaxel
Item
16. female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
boolean
C1283828 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0144576 (UMLS CUI [2,3])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
17. female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Patient Inappropriate OCT Evaluation
Item
18. patient that in the opinion of the investigator is not clinically appropriate for oct evaluation.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
Exclusion Criteria Angiography
Item
angiographic exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Thrombus Vessel Involved | Angiography | IVUS
Item
1. evidence of thrombus of the study vessel, based on angiography or ivus
boolean
C0087086 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0002978 (UMLS CUI [2])
C0206520 (UMLS CUI [3])
Lesion Occluded Total | TIMI Flow Grade
Item
2. study lesion is totally occluded (timi flow ≤ 1) either at baseline or before pre-dilatation
boolean
C0221198 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2,1])
C4263591 (UMLS CUI [2,2])
Lesion Calcified Moderate | Lesion Calcified Severe | Vessel Calcified Moderate | Vessel Calcified Severe
Item
3. study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0175895 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0005847 (UMLS CUI [3,1])
C0175895 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0005847 (UMLS CUI [4,1])
C0175895 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Lesion Location Ostium | Lesion Distance Vessel origin
Item
4. study lesion is ostial in location (within 3.0 mm of vessel origin)
boolean
C0221198 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0444567 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0012751 (UMLS CUI [2,2])
C1301415 (UMLS CUI [2,3])
Lesion Involving Tortuous coronary artery | Lesion Location Vessel Tortuosity
Item
5. study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
boolean
C0221198 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1272586 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C0333076 (UMLS CUI [2,4])
Lesion Involving Bifurcation | Branch Vessel Percent Diameter Stenosis Measurement
Item
6. study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel > 2.0 mm in diameter
boolean
C0221198 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C3146289 (UMLS CUI [1,3])
C1253959 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C3897965 (UMLS CUI [2,3])
Left main coronary artery disease | Stenosis Percent
Item
7. left main coronary artery disease (stenosis >50%) whether protected or unprotected
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Target Lesion Length
Item
8. target lesion length > 25 mm, based on visual estimate by operator
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Target vessel Diameter Size
Item
9. target vessel diameter > 3.5 mm, based on visual estimate by operator
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Target vessel Diameter Size
Item
10. target vessel diameter < 2.75 mm based on visual estimate by operator
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Pretreatment Target Lesion Using Investigational Medical Device | Exception Dilatation
Item
11. pre-treatment of the target lesion (excluding predilation) with another interventional device.
boolean
C3539076 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2346570 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1322279 (UMLS CUI [2,2])