ID

28550

Description

China Endeavor Registry: A Registry With The Endeavor Zotarolimus Eluting Coronary Stent in China; ODM derived from: https://clinicaltrials.gov/show/NCT00793312

Lien

https://clinicaltrials.gov/show/NCT00793312

Mots-clés

Versions (1)
  1. 21/01/2018 21/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 janvier 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00793312

Anglais

Eligibility Coronary Artery Disease NCT00793312

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is > 18 years of age (or minimum age as required by local regulations).
Description

Age

Type de données

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".
Description

Informed Consent | Patient data Release of information consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C2707520
UMLS CUI [2,2]
C3166272
patient is suitable for implantation of one or more endeavor™ zotaroliums eluting coronary stent system in one or more native artery target lesions.
Description

Patient Appropriate Placement of stent | Implantation Zotarolimus Drug-Eluting Stent Quantity | Artery Native Target Lesion Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0522776
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C1700035
UMLS CUI [2,3]
C1322815
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0003842
UMLS CUI [3,2]
C0302891
UMLS CUI [3,3]
C2986546
UMLS CUI [3,4]
C1265611
patient indication, 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™ zotarolimus eluting coronary stent system.
Description

Patient Indication of Target Lesion | Target Lesion Length | Target Lesion Vessel Diameter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2986546
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1444754
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0005847
UMLS CUI [3,3]
C1301886
the patient is willing and able to cooperate with registry procedures and required follow up
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

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

Pregnancy | Breast Feeding

Type de données

boolean

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

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

Type de données

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
patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
Description

Medical contraindication Antiplatelet therapy | Medical contraindication Anticoagulation Therapy

Type de données

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.
Description

Lesion Preventing Inflation Angioplasty Balloon

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1283105
UMLS CUI [1,4]
C0002996
current medical condition with a life expectancy of less than 12 months.
Description

Medical condition Resulting in Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
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 registry once.
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C0205197
patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
Description

Medical condition Excludes Clinical Study Follow-up | Medical condition Study Subject Participation Status Limited

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
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 NCT00793312

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is > 18 years of age (or minimum age as required by local regulations).
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Patient data Release of information 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])
C2707520 (UMLS CUI [2,1])
C3166272 (UMLS CUI [2,2])
Patient Appropriate Placement of stent | Implantation Zotarolimus Drug-Eluting Stent Quantity | Artery Native Target Lesion Quantity
Item
patient is suitable for implantation of one or more endeavor™ zotaroliums eluting coronary stent system in one or more native artery target lesions.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0522776 (UMLS CUI [1,3])
C0021107 (UMLS CUI [2,1])
C1700035 (UMLS CUI [2,2])
C1322815 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0003842 (UMLS CUI [3,1])
C0302891 (UMLS CUI [3,2])
C2986546 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Patient Indication of Target Lesion | Target Lesion Length | Target Lesion Vessel Diameter
Item
patient indication, 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™ zotarolimus eluting coronary stent system.
boolean
C0030705 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C2986546 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
Protocol Compliance
Item
the patient is willing and able to cooperate with registry procedures and required follow up
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 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
patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as zotaroliums, 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])
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 Antiplatelet therapy | Medical contraindication Anticoagulation Therapy
Item
patients in whom anti-platelet and/or 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 Inflation 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])
C1283105 (UMLS CUI [1,3])
C0002996 (UMLS CUI [1,4])
Medical condition Resulting in Life Expectancy
Item
current medical condition with a life expectancy of less than 12 months.
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Clinical Study Follow-up Completed
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 registry once.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C3274571 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Medical condition Excludes 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])
C0332196 (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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