age
Item
the patient is at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ischemic heart disease
Item
the patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
boolean
C0151744 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0340291 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
cndidate for percutaneous transluminal coronary angioplasty, stenting, coronary artery bybass graft surgery
Item
the patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergent coronary artery bypass graft (cabg) surgery.
boolean
C2936173 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0687568 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
women of childbearing potential pregnancy test
Item
female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
boolean
C1960468 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
informed consent
Item
the patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
boolean
C0021430 (UMLS CUI [1])
contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidgrel, cobalt, nickel, chromium, molybdenum, polymer coatings or contrast media
Item
a known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
boolean
C0522473 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0522473 (UMLS CUI [3,1])
C0168273 (UMLS CUI [3,2])
C0522473 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0522473 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C0522473 (UMLS CUI [6,1])
C0009148 (UMLS CUI [6,2])
C0522473 (UMLS CUI [7,1])
C0028013 (UMLS CUI [7,2])
C0522473 (UMLS CUI [8,1])
C0008574 (UMLS CUI [8,2])
C0522473 (UMLS CUI [9,1])
C0026402 (UMLS CUI [9,2])
C0522473 (UMLS CUI [10,1])
C0032521 (UMLS CUI [10,2])
C0522473 (UMLS CUI [11,1])
C0009924 (UMLS CUI [11,2])
allergy to abt-578, rapamycin, tacrolimus, everolimus
Item
history of an allergic reaction or significant sensitivity to drugs similar to abt-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
boolean
C0020517 (UMLS CUI [1,1])
C2350862 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0085149 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
platelet count, white blood cell count
Item
a platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (wbc) count < 3,000 cells/mm³.
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
creatinine level, acute myocardial infarction
Item
a creatinine level > 2.0 mg/dl within seven days prior to index procedure. evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: q wave or non-q wave myocardial infarction having creatine kinase [ck] enzymes greater than or equal to 2 x the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme [ck-mb] elevated above the institution's upper limit of normal).
boolean
C0010294 (UMLS CUI [1])
C0155626 (UMLS CUI [2,1])
C0010287 (UMLS CUI [2,2])
C0010290 (UMLS CUI [2,3])
percutaneous coronary intervention
Item
previous percutaneous coronary intervention (pci) of the target vessel within 9 months pre-procedure.
boolean
C1532338 (UMLS CUI [1])
percutaneous coronary intervention
Item
planned pci of any vessel within 30 days post-procedure.
boolean
C1532338 (UMLS CUI [1])
other treatment than percutaneous transluminal coronary angioplasty
Item
during the index procedure, the target lesion requires treatment with a device other than ptca prior to stent placement (such as, but not limited to: cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
boolean
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2936173 (UMLS CUI [1,3])
stroke, transient ischemic attack, peptic ulcer, upper gastrointestinal bleeding
Item
history of a stroke or transient ischemic attack within the prior 6 months. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0041909 (UMLS CUI [4])
bleeding diathesis, coagulopathy, blood transfusion
Item
history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
boolean
C0005779 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
life expectancy, concurrent therapy
Item
concurrent medical condition with a life expectancy of less than 12 months. any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to, brachytherapy.
boolean
C0023671 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
study participation status
Item
currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (ivus) or other coronary artery imaging procedures.
boolean
C2348568 (UMLS CUI [1])