ID

28469

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00617084

Stichworte

Versionen (1)
  1. 16.01.18 16.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00617084

Englisch

Eligibility Coronary Artery Disease NCT00617084

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
minimal age 18 years
Beschreibung

Age Minimum

Datentyp

boolean

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

Coronary Artery Disease Symptomatic

Datentyp

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
Beschreibung

Patient Appropriate Therapeutic procedure Drug-Eluting Stent

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Patient Indication | Stenotic lesion length | Vessel Diameter

Datentyp

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.
Beschreibung

Protocol Compliance | Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

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

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
Beschreibung

Childbearing Potential Pregnancy test negative Lacking | Breast Feeding

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Study Subject Participation Status | Primary Endpoint failed

Datentyp

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.
Beschreibung

Operative Surgical Procedures Planned | Exception Antiplatelet therapy Maintained

Datentyp

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
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00617084

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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