ID

28583

Beschrijving

Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.; ODM derived from: https://clinicaltrials.gov/show/NCT00850213

Link

https://clinicaltrials.gov/show/NCT00850213

Trefwoorden

Versies (1)
  1. 23-01-18 23-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00850213

Engels

Eligibility Coronary Artery Disease NCT00850213

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is >18 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subject has agreed to participate in the study by signing the "patient informed consent" and/or has authorized the collection and disclosure of their personal health information by signing the "patient data collection form".
Beschrijving

Informed Consent | Release Personal Health Information

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1283071
UMLS CUI [2,2]
C4045976
there is an indication for a drug-eluting stent and a clinical decision to use endeavor resolute in all the lesions found.
Beschrijving

Indication Drug-Eluting Stent | Drug-Eluting Stent Specified Lesion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1322815
UMLS CUI [2,1]
C1322815
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C0221198
subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is a childbearing or breastfeeding female.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media.
Beschrijving

Aspirin allergy | Heparin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Zotarolimus | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Analogue | Hypersensitivity Derivative | Hypersensitivity Cobalt | Hypersensitivity Chromium | Allergy to nickel | Hypersensitivity Molybdenum | Contrast media allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0040207
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1700035
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0072980
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0085149
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0013227
UMLS CUI [8,3]
C2348205
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0243071
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C1527240
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0009148
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0008574
UMLS CUI [13]
C1690547
UMLS CUI [14,1]
C0020517
UMLS CUI [14,2]
C0026402
UMLS CUI [15]
C0570562
subject has a contraindication to anticoagulants and/or antiplatelets.
Beschrijving

Medical contraindication Anticoagulants | Medical contraindication Antiplatelet Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0085826
subject's lesion might prevent proper balloon inflation during angioplasty.
Beschrijving

Lesion Preventing Balloon Angioplasty

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0002996
primary or rescue angioplasty.
Beschrijving

Angioplasty Primary | Emergency Angioplasty

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162577
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0013956
UMLS CUI [2,2]
C0162577
subject has one or more drug-eluting stents other than endeavor resolute in other lesions.
Beschrijving

Drug-Eluting Stents Quantity | Exception Drug-Eluting Stents Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1322815
UMLS CUI [2,3]
C0205369
intention for elective treatment with other drug-eluting stent other than endeavor resolute.
Beschrijving

Therapeutic procedure elective Drug-Eluting Stents | Exception Drug-Eluting Stents Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C1322815
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1322815
UMLS CUI [2,3]
C0205369
current medical condition is associated with a life expectancy ≤ 12 months.
Beschrijving

Medical condition Associated with Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023671
subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. subject can only be enrolled once in this study.
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Study Follow-up Incomplete

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C0205257
subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study.
Beschrijving

Medical condition Preventing Follow-up | Medical condition Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
subject cannot guarantee follow-up.
Beschrijving

Follow-up Participation Uncertain

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0087130
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Similar models

Eligibility Coronary Artery Disease NCT00850213

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is >18 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Release Personal Health Information
Item
subject has agreed to participate in the study by signing the "patient informed consent" and/or has authorized the collection and disclosure of their personal health information by signing the "patient data collection form".
boolean
C0021430 (UMLS CUI [1])
C1283071 (UMLS CUI [2,1])
C4045976 (UMLS CUI [2,2])
Indication Drug-Eluting Stent | Drug-Eluting Stent Specified Lesion
Item
there is an indication for a drug-eluting stent and a clinical decision to use endeavor resolute in all the lesions found.
boolean
C3146298 (UMLS CUI [1,1])
C1322815 (UMLS CUI [1,2])
C1322815 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Protocol Compliance
Item
subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
subject is a childbearing or breastfeeding female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Aspirin allergy | Heparin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Zotarolimus | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | Hypersensitivity Pharmaceutical Preparations Similar | Hypersensitivity Analogue | Hypersensitivity Derivative | Hypersensitivity Cobalt | Hypersensitivity Chromium | Allergy to nickel | Hypersensitivity Molybdenum | Contrast media allergy
Item
subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media.
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1700035 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0072980 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0085149 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
C2348205 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0243071 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C1527240 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0009148 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0008574 (UMLS CUI [12,2])
C1690547 (UMLS CUI [13])
C0020517 (UMLS CUI [14,1])
C0026402 (UMLS CUI [14,2])
C0570562 (UMLS CUI [15])
Medical contraindication Anticoagulants | Medical contraindication Antiplatelet Agents
Item
subject has a contraindication to anticoagulants and/or antiplatelets.
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0085826 (UMLS CUI [2,2])
Lesion Preventing Balloon Angioplasty
Item
subject's lesion might prevent proper balloon inflation during angioplasty.
boolean
C0221198 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0002996 (UMLS CUI [1,3])
Angioplasty Primary | Emergency Angioplasty
Item
primary or rescue angioplasty.
boolean
C0162577 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0013956 (UMLS CUI [2,1])
C0162577 (UMLS CUI [2,2])
Drug-Eluting Stents Quantity | Exception Drug-Eluting Stents Specified
Item
subject has one or more drug-eluting stents other than endeavor resolute in other lesions.
boolean
C1322815 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Therapeutic procedure elective Drug-Eluting Stents | Exception Drug-Eluting Stents Specified
Item
intention for elective treatment with other drug-eluting stent other than endeavor resolute.
boolean
C0087111 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C1322815 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Medical condition Associated with Life Expectancy
Item
current medical condition is associated with a life expectancy ≤ 12 months.
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Study Follow-up Incomplete
Item
subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. subject can only be enrolled once in this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C3274571 (UMLS CUI [4,1])
C0205257 (UMLS CUI [4,2])
Medical condition Preventing Follow-up | Medical condition Study Subject Participation Status Limited
Item
subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Follow-up Participation Uncertain
Item
subject cannot guarantee follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0087130 (UMLS CUI [1,3])
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