Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Eligibility Percutaneous Coronary Intervention
Item
1. eligible for percutaneous coronary intervention (pci).
boolean
C0680253 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Stable angina | Angina, Unstable
Item
2. documented stable or unstable angina pectoris
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Left ventricular ejection fraction
Item
3. left ventricular ejection fraction (lvef) ≥25%
boolean
C0428772 (UMLS CUI [1])
Indication Coronary Artery Bypass Surgery
Item
4. acceptable candidate for coronary artery bypass graft surgery (cabg).
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Target Lesion Length | Reference Vessel Diameter | Stenosis Percentage
Item
5. target lesion < 25 mm in length with rvd of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C1261287 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Exclusion Criteria General
Item
general exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Hypersensitivity Pimecrolimus | Hypersensitivity PLGA | Hypersensitivity Cobalt-Chromium
Item
1. known sensitivity to pimecrolimus, the polymer (plga) or cobalt chromium.
boolean
C0020517 (UMLS CUI [1,1])
C1099414 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0071599 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0008576 (UMLS CUI [3,2])
Planned Treatment Percutaneous Coronary Intervention Device Target vessel
Item
2. planned treatment with any other pci device in the target vessel(s).
boolean
C3641097 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0449618 (UMLS CUI [1,4])
Myocardial Infarction
Item
3. mi within 72 hours prior to the index procedure
boolean
C0027051 (UMLS CUI [1])
Shock, Cardiogenic
Item
4. the patient is in cardiogenic shock.
boolean
C0036980 (UMLS CUI [1])
Cerebrovascular accident
Item
5. cerebrovascular accident (cva) within the past 6 months.
boolean
C0038454 (UMLS CUI [1])
Renal dysfunction | Renal dysfunction chronic
Item
6. acute or chronic renal dysfunction
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Medical contraindication Aspirin | Medical contraindication clopidogrel
Item
7. contraindication to asa or to clopidogrel.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
Thrombocytopenia
Item
8. thrombocytopenia
boolean
C0040034 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
9. active gastrointestinal (gi) bleeding within the past 3 months.
boolean
C0017181 (UMLS CUI [1])
Anaphylactoid reaction Contrast Media
Item
10. any prior true anaphylactiod reaction to contrast agents
boolean
C0340865 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
systemic steroids chronic | Therapeutic immunosuppression Systemic | Pimecrolimus Topical
Item
11. patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
boolean
C2825233 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C3213133 (UMLS CUI [3])
Childbearing Potential
Item
12. female of childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Life Expectancy Due to Other medical condition
Item
13. life expectancy of less than 24 months due to other medical conditions.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Comorbidity
Item
14. co-morbid condition(s)
boolean
C0009488 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
15. currently participating in another investigational drug or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])