Age
Item
subject is ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Indication Percutaneous Coronary Intervention | Single lesion Requirement Therapeutic procedure
Item
subject is eligible for percutaneous coronary intervention (pci) and has a single lesion requiring treatment.
boolean
C3146298 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0577304 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Indication Coronary Artery Bypass Surgery
Item
subject is an acceptable candidate for cabg.
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Myocardial Ischemia Evidence Clinical | Cardiac Function Study Positive
Item
subject has clinical evidence of ischemic heart disease or a positive functional study.
boolean
C0151744 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1516291 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Stable angina
Item
subject has documented stable angina pectoris
boolean
C0340288 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria include all of the following:
boolean
C0680251 (UMLS CUI [1])
Acute myocardial infarction Evidence of | Creatine kinase MB measurement
Item
evidence of an acute myocardial infarction (ami) or ck-mb > 2x upper limit of normal within 72 hours of the intended treatment (refer to who definition).
boolean
C0155626 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0523584 (UMLS CUI [2])
Hypersensitivity Aspirin | Hypersensitivity Clopidogrel bisulfate | Hypersensitivity Plavix | Hypersensitivity Ticlopidine | Hypersensitivity Ticlid | Hypersensitivity Heparin | Hypersensitivity Stainless Steel | Hypersensitivity Tantalum | Hypersensitivity Contrast Media | Hypersensitivity Paclitaxel | Hypersensitivity ABT-578 | Hypersensitivity Tacrolimus | Hypersensitivity Sirolimus | Hypersensitivity everolimus
Item
known allergies to the following: aspirin, clopidogrel bisulfate (plavix®) or ticlopidine (ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to abt-578 (i.e. tacrolimus, sirolimus, everolimus).
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0772326 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0633084 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0733418 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0019134 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0038126 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0039297 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0009924 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0144576 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C2350862 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0085149 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0072980 (UMLS CUI [13,2])
C0020517 (UMLS CUI [14,1])
C0541315 (UMLS CUI [14,2])
Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin
Item
a platelet count < 100 x 109/l or > 700 x 109/l (< 100,000 cells/mm3 or > 700,000 cells/mm3); a wbc < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl.
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum
Item
acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/l).
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Brachytherapy Target vessel
Item
subject has had any previous or planned brachytherapy in the target vessel.
boolean
C0006098 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Target vessel Thrombus Evidence of | Target vessel Tortuous Excessive | Target vessel Inappropriate Placement of stent
Item
target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.
boolean
C0449618 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0449618 (UMLS CUI [2,1])
C4068863 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C0449618 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0522776 (UMLS CUI [3,3])