ID

20459

Beschrijving

E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00623441

Link

https://clinicaltrials.gov/show/NCT00623441

Trefwoorden

Versies (1)
  1. 23-02-17 23-02-17 -
Geüploaded op

23 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00623441

Engels

Eligibility Coronary Artery Disease NCT00623441

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is >18 years of age (or minimum age as required by local regulation)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the patient has consented to participate by signing the "patient informed consent form" and/or has authorized the collection and release of his medical information by signing the "patient data release consent form".
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
the patient is suitable for implantation of one or more endeavor(tm) abt-578 eluting coronary stent system in one or more native artery target lesions.
Beschrijving

Drug-eluting coronary stent placement ABT-578 Quantity | Target Lesion Coronary artery Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2609296
UMLS CUI [1,2]
C2350862
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0205042
UMLS CUI [2,3]
C1265611
lesion length and vessel diameter of the target lesion(s) are according to the "indications for use" as mentioned in the "instructions for use" that comes with every endeavor(tm) abt-578 eluting coronary stent system.
Beschrijving

Target Lesion Length | Target Lesion Vessel Diameter | Drug-Eluting Coronary Stent ABT-578

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C1262327
UMLS CUI [3,2]
C2350862
the patient is willing and able to cooperate with registry procedures and required follow up visits.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with known pregnancy or who are lactating.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as abt-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
Beschrijving

Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity ABT-578 | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | 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]
C2350862
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]
C0009148
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0008574
UMLS CUI [10]
C1690547
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0026402
UMLS CUI [12]
C0570562
patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
Beschrijving

Medical contraindication Antiplatelet therapy | Medical contraindication Anticoagulation Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1096021
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003281
patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Beschrijving

Lesion Preventing Angioplasty Balloon

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0002996
current medical condition with a life expectancy of less than 12 months.
Beschrijving

medical condition Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0023671
the subject is participating in another device or drug study. subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. the subject may only be enrolled in this e-five registry once.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
Beschrijving

medical condition Exclude Clinical Study Follow-up | medical condition Study Subject Participation Status Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
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Similar models

Eligibility Coronary Artery Disease NCT00623441

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is >18 years of age (or minimum age as required by local regulation)
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
the patient has consented to participate by signing the "patient informed consent form" and/or has authorized the collection and release of his medical information by signing the "patient data release consent form".
boolean
C0021430 (UMLS CUI [1])
Drug-eluting coronary stent placement ABT-578 Quantity | Target Lesion Coronary artery Quantity
Item
the patient is suitable for implantation of one or more endeavor(tm) abt-578 eluting coronary stent system in one or more native artery target lesions.
boolean
C2609296 (UMLS CUI [1,1])
C2350862 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0205042 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Target Lesion Length | Target Lesion Vessel Diameter | Drug-Eluting Coronary Stent ABT-578
Item
lesion length and vessel diameter of the target lesion(s) are according to the "indications for use" as mentioned in the "instructions for use" that comes with every endeavor(tm) abt-578 eluting coronary stent system.
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C1262327 (UMLS CUI [3,1])
C2350862 (UMLS CUI [3,2])
Protocol Compliance
Item
the patient is willing and able to cooperate with registry procedures and required follow up visits.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women with known pregnancy or who are lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity ABT-578 | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | Hypersensitivity Cobalt | Hypersensitivity Chromium | Allergy to nickel | Hypersensitivity Molybdenum | Contrast media allergy
Item
patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as abt-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, 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])
C2350862 (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])
C0009148 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0008574 (UMLS CUI [9,2])
C1690547 (UMLS CUI [10])
C0020517 (UMLS CUI [11,1])
C0026402 (UMLS CUI [11,2])
C0570562 (UMLS CUI [12])
Medical contraindication Antiplatelet therapy | Medical contraindication Anticoagulation Therapy
Item
patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C1096021 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
Lesion Preventing Angioplasty Balloon
Item
patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
boolean
C0221198 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0002996 (UMLS CUI [1,3])
medical condition Life Expectancy
Item
current medical condition with a life expectancy of less than 12 months.
boolean
C3843040 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
the subject is participating in another device or drug study. subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. the subject may only be enrolled in this e-five registry once.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
medical condition Exclude Clinical Study Follow-up | medical condition Study Subject Participation Status Limited
Item
patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
boolean
C3843040 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
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