ID

16883

Description

V-Flex Plus PTX Drug Eluting Coronary Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00225693

Link

https://clinicaltrials.gov/show/NCT00225693

Keywords

Versions (1)
  1. 8/12/16 8/12/16 -
Uploaded on

August 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00225693

English

Eligibility Coronary Artery Disease NCT00225693

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

Lesion de novo Single Coronary artery Native | Therapeutic procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205171
UMLS CUI [1,4]
C0205042
UMLS CUI [1,5]
C0302891
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1301732
patient must be an acceptable candidate for coronary artery bypass surgery
Description

Indication Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
patient or legal guardian must have given informed consent
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
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, an ivus examination and a diagnostic angiogram.
Description

Office Visit Assessment Status Cardiovascular | Ultrasonography, Intravascular | angiogram

Data type

boolean

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C3887460
UMLS CUI [2]
C0206520
UMLS CUI [3]
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

Bleeding tendency | Blood Coagulation Disorders | transfusion blood refusal

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0749628
patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
Description

Study Subject Participation Status Cardiovascular investigation | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0455796
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
Description

Hypersensitivity Aspirin | Medical contraindication Aspirin | Hypersensitivity clopidogrel | Medical contraindication clopidogrel | Hypersensitivity Stainless Steel | Medical contraindication Stainless Steel | contrast dye allergy

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

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
Description

Other medical condition Protocol Compliance Limited | Other medical condition Interferes with research results | Other medical condition Associated with Life Expectancy Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0023671
UMLS CUI [3,4]
C0439801
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Similar models

Eligibility Coronary Artery Disease NCT00225693

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lesion de novo Single Coronary artery Native | Therapeutic procedure Planned
Item
patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0205042 (UMLS CUI [1,4])
C0302891 (UMLS CUI [1,5])
C0087111 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Indication Coronary Artery Bypass Surgery
Item
patient must be an acceptable candidate for coronary artery bypass surgery
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Informed Consent | Informed Consent Legal Guardian
Item
patient or legal guardian must have given informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Office Visit Assessment Status Cardiovascular | Ultrasonography, Intravascular | 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, an ivus examination and a diagnostic angiogram.
boolean
C0028900 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C3887460 (UMLS CUI [1,4])
C0206520 (UMLS CUI [2])
C0002978 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Age
Item
patient must be less than 18 years old
boolean
C0001779 (UMLS CUI [1])
Bleeding tendency | Blood Coagulation Disorders | transfusion blood refusal
Item
patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0749628 (UMLS CUI [3])
Study Subject Participation Status Cardiovascular investigation | Investigational New Drugs | Investigational Medical Device
Item
patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
boolean
C2348568 (UMLS CUI [1,1])
C0455796 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Hypersensitivity Aspirin | Medical contraindication Aspirin | Hypersensitivity clopidogrel | Medical contraindication clopidogrel | Hypersensitivity Stainless Steel | Medical contraindication Stainless Steel | contrast dye allergy
Item
patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
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])
Childbearing Potential
Item
women of child bearing potential.
boolean
C3831118 (UMLS CUI [1])
Other medical condition Protocol Compliance Limited | Other medical condition Interferes with research results | Other medical condition Associated with Life Expectancy Limited
Item
patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
boolean
C3843040 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
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