ID

28558

Description

Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography; ODM derived from: https://clinicaltrials.gov/show/NCT00815139

Link

https://clinicaltrials.gov/show/NCT00815139

Keywords

Versions (1)
  1. 1/22/18 1/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00815139

English

Eligibility Coronary Artery Disease NCT00815139

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
significant coronary de novo lesion ( > 70% by quantitative angiographic analysis)
Description

Lesion Coronary de novo Percentage | Angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C1515568
UMLS CUI [1,4]
C0439165
UMLS CUI [2]
C0002978
patients with stable or acute coronary syndrome considered for coronary revascularization.
Description

Syndrome Coronary Stable | Acute Coronary Syndrome | Coronary revascularisation considered

Data type

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0948089
UMLS CUI [3,1]
C0877341
UMLS CUI [3,2]
C0750591
non-emergent conditions
Description

Medical condition | Exception Emergency

Data type

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013956
reference vessel diameter of 2.75 to 4.0 mm by operator assessment
Description

Reference Vessel Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the criteria for exclusion were contraindication to anti-platelet agents
Description

Medical contraindication Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085826
st elevation mi requiring primary pci
Description

ST segment elevation myocardial infarction Requirement Percutaneous Coronary Intervention Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1532338
UMLS CUI [1,4]
C0205225
proximal lesion within 15 mm from ostium
Description

Lesion Proximal Distance Ostium

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205107
UMLS CUI [1,3]
C0012751
UMLS CUI [1,4]
C0444567
prior insertion of other des in any vessel
Description

Drug-Eluting Stent Insertion Vessel Any

Data type

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C1552551
creatinine level more than 2.0mg/dl or esrd
Description

Creatinine measurement, serum | End stage renal disease

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0022661
severe hepatic dysfunction (more than 3 times normal reference values)
Description

Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
pregnant women or women with potential childbearing
Description

Pregnancy | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
life expectancy less than 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
complex lesion morphologies (aorto-ostial, bifurcation with >2.0 mm side branch, unprotected left main, thrombus, severe calcification, chronic total occlusion)
Description

Lesion Morphology Complex | Ostium of aorta | Bifurcation | Size Side Branch of Artery | Left coronary artery | Thrombus | Calcification Severe | Chronic total occlusion of coronary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0543482
UMLS CUI [1,3]
C0439855
UMLS CUI [2]
C0503899
UMLS CUI [3]
C3146289
UMLS CUI [4,1]
C0456389
UMLS CUI [4,2]
C0441987
UMLS CUI [4,3]
C1253959
UMLS CUI [4,4]
C0003842
UMLS CUI [5]
C1261082
UMLS CUI [6]
C0087086
UMLS CUI [7,1]
C0175895
UMLS CUI [7,2]
C0205082
UMLS CUI [8]
C1955779
target lesion is vein graft lesion
Description

Target Lesion Identification Vein Graft Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0042449
UMLS CUI [1,3]
C0332835
UMLS CUI [1,4]
C0221198
reference vessel <2.5 mm or >4.0 mm diameter by visual estimation
Description

Reference Vessel Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
long lesion that require more than two stents
Description

Lesion Long | Requirement Stent Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205166
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0038257
UMLS CUI [2,3]
C1265611
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Similar models

Eligibility Coronary Artery Disease NCT00815139

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lesion Coronary de novo Percentage | Angiography
Item
significant coronary de novo lesion ( > 70% by quantitative angiographic analysis)
boolean
C0221198 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0002978 (UMLS CUI [2])
Syndrome Coronary Stable | Acute Coronary Syndrome | Coronary revascularisation considered
Item
patients with stable or acute coronary syndrome considered for coronary revascularization.
boolean
C0039082 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0948089 (UMLS CUI [2])
C0877341 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
Medical condition | Exception Emergency
Item
non-emergent conditions
boolean
C3843040 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
Reference Vessel Diameter Size
Item
reference vessel diameter of 2.75 to 4.0 mm by operator assessment
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Antiplatelet Agents
Item
the criteria for exclusion were contraindication to anti-platelet agents
boolean
C1301624 (UMLS CUI [1,1])
C0085826 (UMLS CUI [1,2])
ST segment elevation myocardial infarction Requirement Percutaneous Coronary Intervention Primary
Item
st elevation mi requiring primary pci
boolean
C1536220 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Lesion Proximal Distance Ostium
Item
proximal lesion within 15 mm from ostium
boolean
C0221198 (UMLS CUI [1,1])
C0205107 (UMLS CUI [1,2])
C0012751 (UMLS CUI [1,3])
C0444567 (UMLS CUI [1,4])
Drug-Eluting Stent Insertion Vessel Any
Item
prior insertion of other des in any vessel
boolean
C1322815 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,4])
Creatinine measurement, serum | End stage renal disease
Item
creatinine level more than 2.0mg/dl or esrd
boolean
C0201976 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
Liver Dysfunction Severe
Item
severe hepatic dysfunction (more than 3 times normal reference values)
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential
Item
pregnant women or women with potential childbearing
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Life Expectancy
Item
life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Lesion Morphology Complex | Ostium of aorta | Bifurcation | Size Side Branch of Artery | Left coronary artery | Thrombus | Calcification Severe | Chronic total occlusion of coronary artery
Item
complex lesion morphologies (aorto-ostial, bifurcation with >2.0 mm side branch, unprotected left main, thrombus, severe calcification, chronic total occlusion)
boolean
C0221198 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C0503899 (UMLS CUI [2])
C3146289 (UMLS CUI [3])
C0456389 (UMLS CUI [4,1])
C0441987 (UMLS CUI [4,2])
C1253959 (UMLS CUI [4,3])
C0003842 (UMLS CUI [4,4])
C1261082 (UMLS CUI [5])
C0087086 (UMLS CUI [6])
C0175895 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1955779 (UMLS CUI [8])
Target Lesion Identification Vein Graft Lesion
Item
target lesion is vein graft lesion
boolean
C2986546 (UMLS CUI [1,1])
C0042449 (UMLS CUI [1,2])
C0332835 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,4])
Reference Vessel Diameter Size
Item
reference vessel <2.5 mm or >4.0 mm diameter by visual estimation
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Lesion Long | Requirement Stent Quantity
Item
long lesion that require more than two stents
boolean
C0221198 (UMLS CUI [1,1])
C0205166 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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