ID

20447

Descripción

Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation; ODM derived from: https://clinicaltrials.gov/show/NCT00426049

Link

https://clinicaltrials.gov/show/NCT00426049

Palabras clave

Versiones (1)
  1. 22/2/17 22/2/17 -
Subido en

22 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00426049

Inglés

Eligibility Coronary Artery Disease NCT00426049

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or females, aged >18 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
Descripción

Coronary Artery Disease | Intervention Coronary Scheduled | Bare metal coronary stent placement | Coronary Restenosis de novo | Coronary Restenosis First

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1522318
UMLS CUI [2,3]
C0205539
UMLS CUI [3]
C2609297
UMLS CUI [4,1]
C0948480
UMLS CUI [4,2]
C1515568
UMLS CUI [5,1]
C0948480
UMLS CUI [5,2]
C0205435
3. target lesion must be in a native coronary vessel of 2.25 – 4.0 mm size.
Descripción

Target Lesion Coronary Vessel size

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0010075
UMLS CUI [1,3]
C0456389
4. target lesion has to be of less than or equal to 25 mm length.
Descripción

Target Lesion Length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
5. tandem lesion may be included as long as:
Descripción

Lesion Double

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205173
overall length is less than or equal to 25 mm
Descripción

Lesion Double Length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C1444754
tandem lesion will be treated with one stent and counted as one lesion.
Descripción

Lesion Double Therapeutic procedure Stent Single

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0038257
UMLS CUI [1,5]
C0205171
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following exclusion criteria must not be present at baseline visit 1 (bl1, screening visit prior to coronary intervention). if an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
Descripción

Exclusion Criteria Occurrence Timepoint

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C2348792
1. target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
Descripción

Target Lesion Reference Vessel size

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1706462
UMLS CUI [1,4]
C0456389
2. target lesion is a total occlusion or located at a bifurcation.
Descripción

Target Lesion Obstruction Total | Target Lesion Location Coronary Vessel Bifurcation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0028778
UMLS CUI [1,3]
C0439810
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0450429
UMLS CUI [2,3]
C3640041
3. treatment affords implantation of more than one stent per treated lesion.
Descripción

Lesion Therapeutic procedure Stent Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0038257
UMLS CUI [1,4]
C1265611
4. target lesion was already treated by brachytherapy.
Descripción

Brachytherapy Target Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C2986546
5. target lesion has one or more of the following criteria:
Descripción

Target Lesion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0243161
left main lesion
Descripción

Left coronary artery main stem Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0226031
UMLS CUI [1,2]
C0221198
ostial lesion of the rca
Descripción

Ostium of right coronary artery Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0226045
UMLS CUI [1,2]
C0221198
located at less than 2 mm after the origin of the lad or rcx.
Descripción

Target Lesion Location Anterior descending branch of left coronary artery | Target Lesion Location circumflex branch of left coronary artery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0226032
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0450429
UMLS CUI [2,3]
C0226037
other protocol defined inclusion/exclusion criteria may apply.
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Coronary Artery Disease NCT00426049

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. males or females, aged >18 years.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Intervention Coronary Scheduled | Bare metal coronary stent placement | Coronary Restenosis de novo | Coronary Restenosis First
Item
2. patients with coronary artery disease who are scheduled for coronary intervention with bare metal stent placement for treatment of de novo or first restenosis in a native coronary artery.
boolean
C1956346 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1522318 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C2609297 (UMLS CUI [3])
C0948480 (UMLS CUI [4,1])
C1515568 (UMLS CUI [4,2])
C0948480 (UMLS CUI [5,1])
C0205435 (UMLS CUI [5,2])
Target Lesion Coronary Vessel size
Item
3. target lesion must be in a native coronary vessel of 2.25 – 4.0 mm size.
boolean
C2986546 (UMLS CUI [1,1])
C0010075 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Target Lesion Length
Item
4. target lesion has to be of less than or equal to 25 mm length.
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Lesion Double
Item
5. tandem lesion may be included as long as:
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Lesion Double Length
Item
overall length is less than or equal to 25 mm
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
Lesion Double Therapeutic procedure Stent Single
Item
tandem lesion will be treated with one stent and counted as one lesion.
boolean
C0221198 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0038257 (UMLS CUI [1,4])
C0205171 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Occurrence Timepoint
Item
the following exclusion criteria must not be present at baseline visit 1 (bl1, screening visit prior to coronary intervention). if an exclusion criterion occurred afterwards, e.g., during the coronary intervention, the patient must be excluded from the study.
boolean
C0680251 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
Target Lesion Reference Vessel size
Item
1. target lesion has a reference vessel size of less than 2.25 or more than 4.0 mm diameter.
boolean
C2986546 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1706462 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Target Lesion Obstruction Total | Target Lesion Location Coronary Vessel Bifurcation
Item
2. target lesion is a total occlusion or located at a bifurcation.
boolean
C2986546 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C3640041 (UMLS CUI [2,3])
Lesion Therapeutic procedure Stent Quantity
Item
3. treatment affords implantation of more than one stent per treated lesion.
boolean
C0221198 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Brachytherapy Target Lesion
Item
4. target lesion was already treated by brachytherapy.
boolean
C0006098 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Target Lesion criteria
Item
5. target lesion has one or more of the following criteria:
boolean
C2986546 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Left coronary artery main stem Lesion
Item
left main lesion
boolean
C0226031 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Ostium of right coronary artery Lesion
Item
ostial lesion of the rca
boolean
C0226045 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Target Lesion Location Anterior descending branch of left coronary artery | Target Lesion Location circumflex branch of left coronary artery
Item
located at less than 2 mm after the origin of the lad or rcx.
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0226032 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C0226037 (UMLS CUI [2,3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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