ID

28469

Beskrivning

Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00617084

Länk

https://clinicaltrials.gov/show/NCT00617084

Nyckelord

Versioner (1)
  1. 2018-01-16 2018-01-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 januari 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Coronary Artery Disease NCT00617084

Engelsk

Eligibility Coronary Artery Disease NCT00617084

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
minimal age 18 years
Beskrivning

Age Minimum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1524031
symptomatic coronary artery disease
Beskrivning

Coronary Artery Disease Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0231220
patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
Beskrivning

Patient Appropriate Therapeutic procedure Drug-Eluting Stent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1322815
presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
Beskrivning

Coronary Stenosis Percentage Quantity | Reference Diameter Size | Coronary Stenosis Cover Stent Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
UMLS CUI [3,1]
C0242231
UMLS CUI [3,2]
C1999244
UMLS CUI [3,3]
C0038257
UMLS CUI [3,4]
C1265611
patient indication, lesion length and vessel diameter according to 'instructions for use' of study stents
Beskrivning

Patient Indication | Stenotic lesion length | Vessel Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3146298
UMLS CUI [2]
C1443266
UMLS CUI [3,1]
C0005847
UMLS CUI [3,2]
C1301886
patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing ec approved written informed consent.
Beskrivning

Protocol Compliance | Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
Beskrivning

Childbearing Potential Pregnancy test negative Lacking | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0006147
known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, zotarolimus, everolimus, or contrast material
Beskrivning

Intolerance to Aspirin | Intolerance to clopidogrel | Intolerance to Ticlopidine | Intolerance to Heparin | Intolerance to Cobalt | Intolerance to nickel | Intolerance to Chromium | Intolerance to Molybdenum | Other Coding | Intolerance to zotarolimus | Intolerance to everolimus | Intolerance to Contrast Media

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0040207
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0019134
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0009148
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0028013
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0008574
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0026402
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C3846158
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C1700035
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0541315
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0009924
participating in other trial before reaching primary endpoint
Beskrivning

Study Subject Participation Status | Primary Endpoint failed

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2986535
UMLS CUI [2,2]
C0231175
planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Beskrivning

Operative Surgical Procedures Planned | Exception Antiplatelet therapy Maintained

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1096021
UMLS CUI [2,3]
C1314677
Tillbaka till toppen

Similar models

Eligibility Coronary Artery Disease NCT00617084

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age Minimum
Item
minimal age 18 years
boolean
C0001779 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Coronary Artery Disease Symptomatic
Item
symptomatic coronary artery disease
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient Appropriate Therapeutic procedure Drug-Eluting Stent
Item
patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1322815 (UMLS CUI [1,4])
Coronary Stenosis Percentage Quantity | Reference Diameter Size | Coronary Stenosis Cover Stent Quantity
Item
presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1706462 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C0242231 (UMLS CUI [3,1])
C1999244 (UMLS CUI [3,2])
C0038257 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Patient Indication | Stenotic lesion length | Vessel Diameter
Item
patient indication, lesion length and vessel diameter according to 'instructions for use' of study stents
boolean
C0030705 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1443266 (UMLS CUI [2])
C0005847 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Protocol Compliance | Informed Consent | Informed Consent Patient Representative
Item
patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing ec approved written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0030701 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Pregnancy test negative Lacking | Breast Feeding
Item
women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
Intolerance to Aspirin | Intolerance to clopidogrel | Intolerance to Ticlopidine | Intolerance to Heparin | Intolerance to Cobalt | Intolerance to nickel | Intolerance to Chromium | Intolerance to Molybdenum | Other Coding | Intolerance to zotarolimus | Intolerance to everolimus | Intolerance to Contrast Media
Item
known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, zotarolimus, everolimus, or contrast material
boolean
C1744706 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0009148 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0028013 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0008574 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0026402 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C3846158 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C1700035 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0541315 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0009924 (UMLS CUI [12,2])
Study Subject Participation Status | Primary Endpoint failed
Item
participating in other trial before reaching primary endpoint
boolean
C2348568 (UMLS CUI [1])
C2986535 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Operative Surgical Procedures Planned | Exception Antiplatelet therapy Maintained
Item
planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1096021 (UMLS CUI [2,2])
C1314677 (UMLS CUI [2,3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial