ID

14024

Description

The ELUTES Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00225654

Link

https://clinicaltrials.gov/show/NCT00225654

Keywords

Versions (1)
  1. 3/22/16 3/22/16 -
Uploaded on

March 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00225654

English

Eligibility Coronary Artery Disease NCT00225654

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
Description

Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0013893
patient must be an acceptable candidate for coronary artery bypass surgery.
Description

Coronary artery bypass surgery

Data type

boolean

Alias
UMLS CUI [1]
C0010055
patient or legal guardian must have signed informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.
Description

Cardiovascular status assessment and angiogram

Data type

boolean

Alias
UMLS CUI [1]
C1255934
UMLS CUI [2]
C0002978
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient must be less than 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Description

Coagulation status

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C1879316
patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
Description

Participating status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye that.
Description

Specific allergies and contraindications

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0070166
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0038126
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0038126
UMLS CUI [7]
C0742797
women of child bearing potential.
Description

Child bearing potential

Data type

boolean

Alias
UMLS CUI [1]
C1960468
patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
Description

Comorbidity and life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0023671
patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.
Description

Diagnosis date: myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027051
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Similar models

Eligibility Coronary Artery Disease NCT00225654

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Eligibility Criteria
Item
patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
boolean
C0013893 (UMLS CUI [1])
Coronary artery bypass surgery
Item
patient must be an acceptable candidate for coronary artery bypass surgery.
boolean
C0010055 (UMLS CUI [1])
Informed consent
Item
patient or legal guardian must have signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Cardiovascular status assessment and angiogram
Item
patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.
boolean
C1255934 (UMLS CUI [1])
C0002978 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patient must be less than 18 years old.
boolean
C0001779 (UMLS CUI [1])
Coagulation status
Item
patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C1879316 (UMLS CUI [3])
Participating status
Item
patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
boolean
C2348568 (UMLS CUI [1])
Specific allergies and contraindications
Item
patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye that.
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0070166 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0038126 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0038126 (UMLS CUI [6,2])
C0742797 (UMLS CUI [7])
Child bearing potential
Item
women of child bearing potential.
boolean
C1960468 (UMLS CUI [1])
Comorbidity and life expectancy
Item
patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Diagnosis date: myocardial infarction
Item
patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.
boolean
C2316983 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
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