ID

28512

Beschrijving

Evaluation of the GTX™ 5126 DES Coronary Stent System in the Treatment of Patients With a Lesion in the Coronary Artery; ODM derived from: https://clinicaltrials.gov/show/NCT00777842

Link

https://clinicaltrials.gov/show/NCT00777842

Trefwoorden

Versies (1)
  1. 21-01-18 21-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00777842

Engels

Eligibility Coronary Artery Disease NCT00777842

1 Formulieren  
Criteria
Beschrijving

Criteria

patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
Beschrijving

Lesion de novo Coronary artery | Myocardial Ischemia Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205042
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0231220
planned treatment of one lesion with a single stent
Beschrijving

Therapeutic procedure Planned Lesion Quantity | Stent Single

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0038257
UMLS CUI [2,2]
C0205171
denovo type a, b1 lesions with a reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm
Beschrijving

Lesion de novo ACC/AHA Lesion Complexity Class | Reference Diameter Size | Lesion Length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C3272276
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1444754
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
diabetic (hba1c >6.0)
Beschrijving

Diabetic | Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0202054
platelet count < 100000 cells/mm3 or > 700000 cells/mm3; wbc < 3000 cells/mm3; or a hemoglobin < 10 g/dl
Beschrijving

Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0518015
renal dysfunction with creatinine > 2.0 mg/dl
Beschrijving

Renal dysfunction | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
patient has a known pre-dilatation ejection fraction (ef) less than forty five (<45%)
Beschrijving

Cardiac ejection fraction Status pre- Dilatation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1322279
myocardial infarction (mi) less than 3 months prior to intervention
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
patient has type b2, c lesion
Beschrijving

Lesion ACC/AHA Lesion Complexity Class

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3272276
reference artery diameter <3.0 or >3.6 mm
Beschrijving

Reference Artery Diameter Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0003842
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
target lesion length < 5mm and >16 mm
Beschrijving

Target Lesion Length

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
other stenosis >50% in target vessel
Beschrijving

Stenosis Percentage Target vessel

Datatype

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0449618
known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.
Beschrijving

Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Cobalt Chrome | Contrast media allergy | Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Cobalt Chrome | Medical contraindication Contrast Media

Datatype

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0008576
UMLS CUI [5]
C0570562
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0004057
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0070166
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0040207
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0008576
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0009924
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Eligibility Coronary Artery Disease NCT00777842

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Lesion de novo Coronary artery | Myocardial Ischemia Symptomatic
Item
patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0151744 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Therapeutic procedure Planned Lesion Quantity | Stent Single
Item
planned treatment of one lesion with a single stent
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0038257 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Lesion de novo ACC/AHA Lesion Complexity Class | Reference Diameter Size | Lesion Length
Item
denovo type a, b1 lesions with a reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C3272276 (UMLS CUI [1,3])
C1706462 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Diabetic | Glucohemoglobin measurement
Item
diabetic (hba1c >6.0)
boolean
C0241863 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin measurement
Item
platelet count < 100000 cells/mm3 or > 700000 cells/mm3; wbc < 3000 cells/mm3; or a hemoglobin < 10 g/dl
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction with creatinine > 2.0 mg/dl
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Cardiac ejection fraction Status pre- Dilatation
Item
patient has a known pre-dilatation ejection fraction (ef) less than forty five (<45%)
boolean
C0232174 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1322279 (UMLS CUI [1,3])
Myocardial Infarction
Item
myocardial infarction (mi) less than 3 months prior to intervention
boolean
C0027051 (UMLS CUI [1])
Lesion ACC/AHA Lesion Complexity Class
Item
patient has type b2, c lesion
boolean
C0221198 (UMLS CUI [1,1])
C3272276 (UMLS CUI [1,2])
Reference Artery Diameter Size
Item
reference artery diameter <3.0 or >3.6 mm
boolean
C1706462 (UMLS CUI [1,1])
C0003842 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Target Lesion Length
Item
target lesion length < 5mm and >16 mm
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Stenosis Percentage Target vessel
Item
other stenosis >50% in target vessel
boolean
C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Cobalt Chrome | Contrast media allergy | Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Cobalt Chrome | Medical contraindication Contrast Media
Item
known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0008576 (UMLS CUI [4,2])
C0570562 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0070166 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0040207 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0008576 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0009924 (UMLS CUI [10,2])
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