ID

40879

Descrizione

Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization; ODM derived from: https://clinicaltrials.gov/show/NCT01342822

collegamento

https://clinicaltrials.gov/show/NCT01342822

Keywords

versioni (1)
  1. 30/05/20 30/05/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

30 maggio 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT01342822

Inglese

Eligibility Ischemic Heart Disease NCT01342822

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria
Descrizione

Inclusion criteria General

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. the patient must be ≥18 of age
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. symptomatic ischemic heart disease (ccs class 1-4, braunwald class ib, ic, and/or objective evidence of myocardial ischemia);
Descrizione

Myocardial Ischemia Symptomatic CCS Class | Myocardial Ischemia Symptomatic Classification | Myocardial Ischemia

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1879987
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0008902
UMLS CUI [3]
C0151744
3. acceptable candidate for cabg;
Descrizione

Eligibility CABG

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0010055
4. the patient is willing to comply with specified follow-up evaluations;
Descrizione

Compliance behavior Follow-up Evaluation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1261322
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).
Descrizione

Informed Consent | Informed Consent Patient Representative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
angiographic inclusion criteria:
Descrizione

Inclusion criteria Angiography

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
6. single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
Descrizione

Coronary artery Lesion Single | Coronary artery Lesion Multiple | Saphenous vein graft Lesion Single | Saphenous vein graft Lesion Multiple | Vessel Single | Vessel Multiple

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0439064
UMLS CUI [3,1]
C0729538
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C0205171
UMLS CUI [4,1]
C0729538
UMLS CUI [4,2]
C0221198
UMLS CUI [4,3]
C0439064
UMLS CUI [5,1]
C0005847
UMLS CUI [5,2]
C0205171
UMLS CUI [6,1]
C0005847
UMLS CUI [6,2]
C0439064
|
NA
7. patients with multi-lesion or multi-vessel coronary disease may undergo staged (planned) procedures within 30-days of the index procedure.
Descrizione

Coronary disease Lesion Multiple | Coronary disease Vessel Multiple | Procedures Planned

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0439064
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0439064
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C1301732
8. reference vessel diameter must be ≥2.25 to ≤ 4.25 mm by visual estimate.
Descrizione

Reference Vessel Diameter

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
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;
Descrizione

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Pregnancy test negative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
2. patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
Descrizione

Medical contraindication Antiplatelet therapy | Medical contraindication Anticoagulant therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1096021
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0150457
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);
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0524930
UMLS CUI [4,2]
C1709854
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0750558
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0681873
UMLS CUI [7,1]
C0038586
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C1858274
UMLS CUI [8]
C0009171
UMLS CUI [9]
C0600241
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;
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3]
C0571776
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0019134
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0168273
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0168273
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0070166
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0070166
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0040207
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0040207
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C1620287
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C1620287
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C0032207
UMLS CUI [13,3]
C0008574
UMLS CUI [13,4]
C0002154
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C0032207
UMLS CUI [14,3]
C0008574
UMLS CUI [14,4]
C0002154
UMLS CUI [15,1]
C0020517
UMLS CUI [15,2]
C0541315
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C0541315
UMLS CUI [17]
C0570562
5. patient with lvef <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
Descrizione

Left ventricular ejection fraction | Shock, Cardiogenic | Impairment Hemodynamic | Pressors Required | Inotropic agents Required | Support device Required

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0036980
UMLS CUI [3,1]
C0221099
UMLS CUI [3,2]
C0019010
UMLS CUI [4,1]
C0237795
UMLS CUI [4,2]
C1514873
UMLS CUI [5,1]
C0304509
UMLS CUI [5,2]
C1514873
UMLS CUI [6,1]
C0183683
UMLS CUI [6,2]
C1514873
6. any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
Descrizione

Other medical condition Interferes with Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
7. currently participating in another investigational drug or device study. -
Descrizione

Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Investigational Medical Device

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
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Similar models

Eligibility Ischemic Heart Disease NCT01342822

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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