ID

16958

Beschreibung

Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries; ODM derived from: https://clinicaltrials.gov/show/NCT00148356

Link

https://clinicaltrials.gov/show/NCT00148356

Stichworte

Versionen (1)
  1. 16.08.16 16.08.16 -
Hochgeladen am

16. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00148356

Englisch

Eligibility Coronary Disease NCT00148356

1 Formulare  
Criteria
Beschreibung

Criteria

subject is ≥ 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
subject is eligible for percutaneous coronary intervention (pci) and has a single lesion requiring treatment.
Beschreibung

Indication Percutaneous Coronary Intervention | Single lesion Requirement Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1532338
UMLS CUI [2,1]
C0577304
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
subject is an acceptable candidate for cabg.
Beschreibung

Indication Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
subject has clinical evidence of ischemic heart disease or a positive functional study.
Beschreibung

Myocardial Ischemia Evidence Clinical | Cardiac Function Study Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C1516291
UMLS CUI [2,2]
C1446409
subject has documented stable angina pectoris
Beschreibung

Stable angina

Datentyp

boolean

Alias
UMLS CUI [1]
C0340288
exclusion criteria include all of the following:
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
evidence of an acute myocardial infarction (ami) or ck-mb > 2x upper limit of normal within 72 hours of the intended treatment (refer to who definition).
Beschreibung

Acute myocardial infarction Evidence of | Creatine kinase MB measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0523584
known allergies to the following: aspirin, clopidogrel bisulfate (plavix®) or ticlopidine (ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to abt-578 (i.e. tacrolimus, sirolimus, everolimus).
Beschreibung

Hypersensitivity Aspirin | Hypersensitivity Clopidogrel bisulfate | Hypersensitivity Plavix | Hypersensitivity Ticlopidine | Hypersensitivity Ticlid | Hypersensitivity Heparin | Hypersensitivity Stainless Steel | Hypersensitivity Tantalum | Hypersensitivity Contrast Media | Hypersensitivity Paclitaxel | Hypersensitivity ABT-578 | Hypersensitivity Tacrolimus | Hypersensitivity Sirolimus | Hypersensitivity everolimus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0772326
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0633084
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0040207
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0733418
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0019134
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0038126
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0039297
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0009924
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0144576
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C2350862
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0085149
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C0072980
UMLS CUI [14,1]
C0020517
UMLS CUI [14,2]
C0541315
a platelet count < 100 x 109/l or > 700 x 109/l (< 100,000 cells/mm3 or > 700,000 cells/mm3); a wbc < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl.
Beschreibung

Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0019046
acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/l).
Beschreibung

Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0201976
subject has had any previous or planned brachytherapy in the target vessel.
Beschreibung

Brachytherapy Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0449618
target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.
Beschreibung

Target vessel Thrombus Evidence of | Target vessel Tortuous Excessive | Target vessel Inappropriate Placement of stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0087086
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0449618
UMLS CUI [2,2]
C4068863
UMLS CUI [2,3]
C0442802
UMLS CUI [3,1]
C0449618
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0522776
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Ähnliche Modelle

Eligibility Coronary Disease NCT00148356

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
subject is ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Indication Percutaneous Coronary Intervention | Single lesion Requirement Therapeutic procedure
Item
subject is eligible for percutaneous coronary intervention (pci) and has a single lesion requiring treatment.
boolean
C3146298 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0577304 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Indication Coronary Artery Bypass Surgery
Item
subject is an acceptable candidate for cabg.
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Myocardial Ischemia Evidence Clinical | Cardiac Function Study Positive
Item
subject has clinical evidence of ischemic heart disease or a positive functional study.
boolean
C0151744 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1516291 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Stable angina
Item
subject has documented stable angina pectoris
boolean
C0340288 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria include all of the following:
boolean
C0680251 (UMLS CUI [1])
Acute myocardial infarction Evidence of | Creatine kinase MB measurement
Item
evidence of an acute myocardial infarction (ami) or ck-mb > 2x upper limit of normal within 72 hours of the intended treatment (refer to who definition).
boolean
C0155626 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0523584 (UMLS CUI [2])
Hypersensitivity Aspirin | Hypersensitivity Clopidogrel bisulfate | Hypersensitivity Plavix | Hypersensitivity Ticlopidine | Hypersensitivity Ticlid | Hypersensitivity Heparin | Hypersensitivity Stainless Steel | Hypersensitivity Tantalum | Hypersensitivity Contrast Media | Hypersensitivity Paclitaxel | Hypersensitivity ABT-578 | Hypersensitivity Tacrolimus | Hypersensitivity Sirolimus | Hypersensitivity everolimus
Item
known allergies to the following: aspirin, clopidogrel bisulfate (plavix®) or ticlopidine (ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to abt-578 (i.e. tacrolimus, sirolimus, everolimus).
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0772326 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0633084 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0733418 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0019134 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0038126 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0039297 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0009924 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0144576 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C2350862 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0085149 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0072980 (UMLS CUI [13,2])
C0020517 (UMLS CUI [14,1])
C0541315 (UMLS CUI [14,2])
Platelet Count measurement | White Blood Cell Count procedure | Hemoglobin
Item
a platelet count < 100 x 109/l or > 700 x 109/l (< 100,000 cells/mm3 or > 700,000 cells/mm3); a wbc < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl.
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum
Item
acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/l).
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Brachytherapy Target vessel
Item
subject has had any previous or planned brachytherapy in the target vessel.
boolean
C0006098 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Target vessel Thrombus Evidence of | Target vessel Tortuous Excessive | Target vessel Inappropriate Placement of stent
Item
target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.
boolean
C0449618 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0449618 (UMLS CUI [2,1])
C4068863 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C0449618 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0522776 (UMLS CUI [3,3])
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