Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
1. the patient must be ≥18 of age
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia Symptomatic CCS Class | Myocardial Ischemia Symptomatic Classification | Myocardial Ischemia
Item
2. symptomatic ischemic heart disease (ccs class 1-4, braunwald class ib, ic, and/or objective evidence of myocardial ischemia);
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1879987 (UMLS CUI [1,3])
C0151744 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0008902 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3])
Eligibility CABG
Item
3. acceptable candidate for cabg;
boolean
C1548635 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Compliance behavior Follow-up Evaluation
Item
4. the patient is willing to comply with specified follow-up evaluations;
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Informed Consent | Informed Consent Patient Representative
Item
5. the patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate medical ethics committee (mec).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Inclusion criteria Angiography
Item
angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Coronary artery Lesion Single | Coronary artery Lesion Multiple | Saphenous vein graft Lesion Single | Saphenous vein graft Lesion Multiple | Vessel Single | Vessel Multiple
Item
6. single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
boolean
C0205042 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0205042 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0729538 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0729538 (UMLS CUI [4,1])
C0221198 (UMLS CUI [4,2])
C0439064 (UMLS CUI [4,3])
C0005847 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C0005847 (UMLS CUI [6,1])
C0439064 (UMLS CUI [6,2])
NA (|)
Coronary disease Lesion Multiple | Coronary disease Vessel Multiple | Procedures Planned
Item
7. patients with multi-lesion or multi-vessel coronary disease may undergo staged (planned) procedures within 30-days of the index procedure.
boolean
C0010068 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
C0010068 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0184661 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Reference Vessel Diameter
Item
8. reference vessel diameter must be ≥2.25 to ≤ 4.25 mm by visual estimate.
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Pregnancy test negative
Item
1. pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Medical contraindication Antiplatelet therapy | Medical contraindication Anticoagulant therapy
Item
2. patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
boolean
C1301624 (UMLS CUI [1,1])
C1096021 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0150457 (UMLS CUI [2,2])
Other medical condition | Malignant Neoplasms | Congestive heart failure | Organ Transplant Recipient | Substance Use Disorders Protocol Compliance Unlikely | Substance Use Disorder Interferes with Interpretation Research data | Substance Use Disorders Associated with Reduced life expectancy | Cocaine Abuse | Heroin abuse
Item
3. patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
boolean
C3843040 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0524930 (UMLS CUI [4,1])
C1709854 (UMLS CUI [4,2])
C0038586 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0750558 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0681873 (UMLS CUI [6,4])
C0038586 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C1858274 (UMLS CUI [7,3])
C0009171 (UMLS CUI [8])
C0600241 (UMLS CUI [9])
Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Hypersensitivity Bivalirudin | Medical contraindication Bivalirudin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel | Hypersensitivity Ticlopidine | Medical contraindication Ticlopidine | Hypersensitivity Prasugrel | Medical contraindication Prasugrel | Hypersensitivity Platinum Chromium Alloy | Medical contraindication Platinum Chromium Alloy | Hypersensitivity Everolimus | Medical contraindication Everolimus | Contrast media allergy
Item
4. patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, platinum chromium alloy, everolimus, and/or contrast sensitivity that cannot be adequately pre-medicated;
boolean
C0004058 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0571776 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0168273 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0168273 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0070166 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0070166 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0040207 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0040207 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C1620287 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C1620287 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0032207 (UMLS CUI [13,2])
C0008574 (UMLS CUI [13,3])
C0002154 (UMLS CUI [13,4])
C1301624 (UMLS CUI [14,1])
C0032207 (UMLS CUI [14,2])
C0008574 (UMLS CUI [14,3])
C0002154 (UMLS CUI [14,4])
C0020517 (UMLS CUI [15,1])
C0541315 (UMLS CUI [15,2])
C1301624 (UMLS CUI [16,1])
C0541315 (UMLS CUI [16,2])
C0570562 (UMLS CUI [17])
Left ventricular ejection fraction | Shock, Cardiogenic | Impairment Hemodynamic | Pressors Required | Inotropic agents Required | Support device Required
Item
5. patient with lvef <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
boolean
C0428772 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
C0221099 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C0237795 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0304509 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0183683 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
Other medical condition Interferes with Study Subject Participation Status
Item
6. any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Investigational Medical Device
Item
7. currently participating in another investigational drug or device study. -
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C2346570 (UMLS CUI [4])