ID

20483

Description

SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe; ODM derived from: https://clinicaltrials.gov/show/NCT00402272

Lien

https://clinicaltrials.gov/show/NCT00402272

Mots-clés

Versions (1)
  1. 25/02/2017 25/02/2017 -
Téléchargé le

25 février 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00402272

Anglais

Eligibility Coronary Disease NCT00402272

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the xience v® eecss and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site
Description

Comprehension Drug-Eluting Coronary Stents Investigational | Informed Consent | Informed Consent Patient Representative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C1262327
UMLS CUI [1,3]
C1517586
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
evidence of myocardial ischemia
Description

Myocardial Ischemia Evidence of

Type de données

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0332120
acceptable candidate for coronary artery bypass graft (cabg) surgery
Description

Indication Coronary Artery Bypass Surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
undergo all cip-required follow-up examinations
Description

Clinical Study Follow-up Receive

Type de données

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1514756
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned xience v® eescc
Description

Artery Morphology Amenable Drug-Eluting Coronary Stents | Disease Amenable Drug-Eluting Coronary Stents | Drug-Eluting Coronary Stents Quantity Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003842
UMLS CUI [1,2]
C0332437
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C1262327
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1262327
UMLS CUI [3,1]
C1262327
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1301732
target lesions must be de novo lesions
Description

Target Lesion de novo

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515568
target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
Description

Target vessel Reference Diameter size

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1706462
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
target lesion ≤ 28 mm in length by visual estimate
Description

Target vessel Length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1444754
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
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Similar models

Eligibility Coronary Disease NCT00402272

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years
boolean
C0001779 (UMLS CUI [1])
Comprehension Drug-Eluting Coronary Stents Investigational | Informed Consent | Informed Consent Patient Representative
Item
able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the xience v® eecss and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site
boolean
C0162340 (UMLS CUI [1,1])
C1262327 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
Myocardial Ischemia Evidence of
Item
evidence of myocardial ischemia
boolean
C0151744 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Indication Coronary Artery Bypass Surgery
Item
acceptable candidate for coronary artery bypass graft (cabg) surgery
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Clinical Study Follow-up Receive
Item
undergo all cip-required follow-up examinations
boolean
C3274571 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Artery Morphology Amenable Drug-Eluting Coronary Stents | Disease Amenable Drug-Eluting Coronary Stents | Drug-Eluting Coronary Stents Quantity Planned
Item
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned xience v® eescc
boolean
C0003842 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C1262327 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1262327 (UMLS CUI [2,3])
C1262327 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Target Lesion de novo
Item
target lesions must be de novo lesions
boolean
C2986546 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Target vessel Reference Diameter size
Item
target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
boolean
C0449618 (UMLS CUI [1,1])
C1706462 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Target vessel Length
Item
target lesion ≤ 28 mm in length by visual estimate
boolean
C0449618 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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