Age
Item
patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Other Coding | Informed Consent
Item
patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the pronova xr des and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site.
boolean
C3846158 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Function Tests Consistent with Ischemia | ECG change Consistent with Ischemia
Item
patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia)
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0542341 (UMLS CUI [5,1])
C0392366 (UMLS CUI [5,2])
C0332290 (UMLS CUI [5,3])
C0022116 (UMLS CUI [5,4])
C4062481 (UMLS CUI [6,1])
C0332290 (UMLS CUI [6,2])
C0022116 (UMLS CUI [6,3])
Agreement Follow-up examination
Item
patient must agree to undergo all required follow-up examinations.
boolean
C0680240 (UMLS CUI [1,1])
C0260832 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Breast Feeding Absent
Item
patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Inclusion criteria Angiography
Item
angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Target Lesion Identification | Lesion de novo | Previous stent placement Absent | Brachytherapy Previous Absent
Item
target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
boolean
C2986546 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C2114504 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006098 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Target vessel Reference Diameter Size
Item
target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
boolean
C0449618 (UMLS CUI [1,1])
C1706462 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C1444754 (UMLS CUI [1,4])
Target Lesion Length
Item
target lesion ≤ 28 mm in length by visual estimate
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Comorbidity | Malignant Neoplasms | Congestive heart failure | Substance Use Disorders | Cocaine Abuse | Heroin abuse | Protocol Compliance Absent | Interference Interpretation Research data | Life Expectancy Limited
Item
patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
boolean
C0009488 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
C0009171 (UMLS CUI [5])
C0600241 (UMLS CUI [6])
C0525058 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0521102 (UMLS CUI [8,1])
C0459471 (UMLS CUI [8,2])
C0681873 (UMLS CUI [8,3])
C0023671 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
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 Cobalt | Medical contraindication Cobalt | Hypersensitivity Chromium | Medical contraindication Chromium | Allergy to nickel | Medical contraindication Nickel | Contrast media allergy | Premedication Unsuccessful
Item
patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, 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])
C0009148 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C0009148 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0008574 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C0008574 (UMLS CUI [14,2])
C1690547 (UMLS CUI [15])
C1301624 (UMLS CUI [16,1])
C0028013 (UMLS CUI [16,2])
C0570562 (UMLS CUI [17])
C0033045 (UMLS CUI [18,1])
C1272705 (UMLS CUI [18,2])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Follow-up Completed
Item
participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C3274571 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Lesion Preventing Inflation Angioplasty Balloon
Item
patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
boolean
C0221198 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1318493 (UMLS CUI [1,3])
C0002996 (UMLS CUI [1,4])