Information:
Fel:
ID
20483
Beskrivning
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe; ODM derived from: https://clinicaltrials.gov/show/NCT00402272
Länk
https://clinicaltrials.gov/show/NCT00402272
Nyckelord
Versioner (1)
- 2017-02-25 2017-02-25 -
Uppladdad den
25 februari 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00402272
Eligibility Coronary Disease NCT00402272
- StudyEvent: Eligibility
Similar models
Eligibility Coronary Disease NCT00402272
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
C1444754 (UMLS CUI [1,2])
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])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])