ID

20532

Description

ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation; ODM derived from: https://clinicaltrials.gov/show/NCT00300131

Link

https://clinicaltrials.gov/show/NCT00300131

Keywords

  1. 3/1/17 3/1/17 -
Uploaded on

March 1, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Coronary Disease NCT00300131

Eligibility Coronary Disease NCT00300131

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
Description

Vessel diameter

Data type

boolean

Alias
UMLS CUI [1]
C1301408
target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
Description

Target size

Data type

boolean

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0005847
the target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a timi flow of greater/equal 1
Description

Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C1261287
non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
Description

Investigational percutaneous intervention in non-target vessel

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C2585119
UMLS CUI [1,3]
C1518389
non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
Description

Investigational percutaneous intervention in target vessel

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C2585119
UMLS CUI [1,3]
C0449618
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
Description

Graft vessel

Data type

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C0005847
lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
Description

Location of lesion

Data type

boolean

Alias
UMLS CUI [1]
C0449685
total occlusion (timi flow 0), prior to wire passing
Description

TIMI flow

Data type

boolean

Alias
UMLS CUI [1]
C3272266
the target vessel contains visible thrombus
Description

Thrombus

Data type

boolean

Alias
UMLS CUI [1]
C0087086
another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
Description

Second lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205436
patient has received brachytherapy in any epicardial vessel (including side branches)
Description

Brachytherapy

Data type

boolean

Alias
UMLS CUI [1]
C0006098

Similar models

Eligibility Coronary Disease NCT00300131

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Vessel diameter
Item
target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
boolean
C1301408 (UMLS CUI [1])
Target size
Item
target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
boolean
C0456389 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
Stenosis
Item
the target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a timi flow of greater/equal 1
boolean
C1261287 (UMLS CUI [1])
Investigational percutaneous intervention in non-target vessel
Item
non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
boolean
C1532338 (UMLS CUI [1,1])
C2585119 (UMLS CUI [1,2])
C1518389 (UMLS CUI [1,3])
Investigational percutaneous intervention in target vessel
Item
non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
boolean
C1532338 (UMLS CUI [1,1])
C2585119 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Graft vessel
Item
located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
boolean
C0332835 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
Location of lesion
Item
lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
boolean
C0449685 (UMLS CUI [1])
TIMI flow
Item
total occlusion (timi flow 0), prior to wire passing
boolean
C3272266 (UMLS CUI [1])
Thrombus
Item
the target vessel contains visible thrombus
boolean
C0087086 (UMLS CUI [1])
Second lesion
Item
another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
boolean
C0221198 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
Brachytherapy
Item
patient has received brachytherapy in any epicardial vessel (including side branches)
boolean
C0006098 (UMLS CUI [1])

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