ID

21452

Beschreibung

The ENDEAVOR Pharmacokinetic (PK) Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System; ODM derived from: https://clinicaltrials.gov/show/NCT00314275

Link

https://clinicaltrials.gov/show/NCT00314275

Stichworte

Versionen (1)
  1. 21.04.17 21.04.17 -
Hochgeladen am

21. April 2017

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00314275

Englisch

Eligibility Coronary Artery Disease NCT00314275

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient is at least 18 years of age.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
the patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
Beschreibung

ischemic heart disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205210
UMLS CUI [3,1]
C0340291
UMLS CUI [3,2]
C0205210
the patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergent coronary artery bypass graft (cabg) surgery.
Beschreibung

cndidate for percutaneous transluminal coronary angioplasty, stenting, coronary artery bybass graft surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2936173
UMLS CUI [1,2]
C0332149
UMLS CUI [2,1]
C0687568
UMLS CUI [2,2]
C0332149
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C0332149
female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
Beschreibung

women of childbearing potential pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0032976
the patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
Beschreibung

contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidgrel, cobalt, nickel, chromium, molybdenum, polymer coatings or contrast media

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C0522473
UMLS CUI [3,2]
C0168273
UMLS CUI [4,1]
C0522473
UMLS CUI [4,2]
C0040207
UMLS CUI [5,1]
C0522473
UMLS CUI [5,2]
C0070166
UMLS CUI [6,1]
C0522473
UMLS CUI [6,2]
C0009148
UMLS CUI [7,1]
C0522473
UMLS CUI [7,2]
C0028013
UMLS CUI [8,1]
C0522473
UMLS CUI [8,2]
C0008574
UMLS CUI [9,1]
C0522473
UMLS CUI [9,2]
C0026402
UMLS CUI [10,1]
C0522473
UMLS CUI [10,2]
C0032521
UMLS CUI [11,1]
C0522473
UMLS CUI [11,2]
C0009924
history of an allergic reaction or significant sensitivity to drugs similar to abt-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
Beschreibung

allergy to abt-578, rapamycin, tacrolimus, everolimus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2350862
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0085149
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0541315
a platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (wbc) count < 3,000 cells/mm³.
Beschreibung

platelet count, white blood cell count

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
a creatinine level > 2.0 mg/dl within seven days prior to index procedure. evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: q wave or non-q wave myocardial infarction having creatine kinase [ck] enzymes greater than or equal to 2 x the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme [ck-mb] elevated above the institution's upper limit of normal).
Beschreibung

creatinine level, acute myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0010294
UMLS CUI [2,1]
C0155626
UMLS CUI [2,2]
C0010287
UMLS CUI [2,3]
C0010290
previous percutaneous coronary intervention (pci) of the target vessel within 9 months pre-procedure.
Beschreibung

percutaneous coronary intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
planned pci of any vessel within 30 days post-procedure.
Beschreibung

percutaneous coronary intervention

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
during the index procedure, the target lesion requires treatment with a device other than ptca prior to stent placement (such as, but not limited to: cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
Beschreibung

other treatment than percutaneous transluminal coronary angioplasty

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2936173
history of a stroke or transient ischemic attack within the prior 6 months. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months.
Beschreibung

stroke, transient ischemic attack, peptic ulcer, upper gastrointestinal bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0030920
UMLS CUI [4]
C0041909
history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Beschreibung

bleeding diathesis, coagulopathy, blood transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0005841
concurrent medical condition with a life expectancy of less than 12 months. any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to, brachytherapy.
Beschreibung

life expectancy, concurrent therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0009429
currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (ivus) or other coronary artery imaging procedures.
Beschreibung

study participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00314275

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
the patient is at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ischemic heart disease
Item
the patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
boolean
C0151744 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0340291 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
cndidate for percutaneous transluminal coronary angioplasty, stenting, coronary artery bybass graft surgery
Item
the patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergent coronary artery bypass graft (cabg) surgery.
boolean
C2936173 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0687568 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
women of childbearing potential pregnancy test
Item
female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
boolean
C1960468 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
informed consent
Item
the patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidgrel, cobalt, nickel, chromium, molybdenum, polymer coatings or contrast media
Item
a known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
boolean
C0522473 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0522473 (UMLS CUI [3,1])
C0168273 (UMLS CUI [3,2])
C0522473 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
C0522473 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C0522473 (UMLS CUI [6,1])
C0009148 (UMLS CUI [6,2])
C0522473 (UMLS CUI [7,1])
C0028013 (UMLS CUI [7,2])
C0522473 (UMLS CUI [8,1])
C0008574 (UMLS CUI [8,2])
C0522473 (UMLS CUI [9,1])
C0026402 (UMLS CUI [9,2])
C0522473 (UMLS CUI [10,1])
C0032521 (UMLS CUI [10,2])
C0522473 (UMLS CUI [11,1])
C0009924 (UMLS CUI [11,2])
allergy to abt-578, rapamycin, tacrolimus, everolimus
Item
history of an allergic reaction or significant sensitivity to drugs similar to abt-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
boolean
C0020517 (UMLS CUI [1,1])
C2350862 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0085149 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
platelet count, white blood cell count
Item
a platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (wbc) count < 3,000 cells/mm³.
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
creatinine level, acute myocardial infarction
Item
a creatinine level > 2.0 mg/dl within seven days prior to index procedure. evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: q wave or non-q wave myocardial infarction having creatine kinase [ck] enzymes greater than or equal to 2 x the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme [ck-mb] elevated above the institution's upper limit of normal).
boolean
C0010294 (UMLS CUI [1])
C0155626 (UMLS CUI [2,1])
C0010287 (UMLS CUI [2,2])
C0010290 (UMLS CUI [2,3])
percutaneous coronary intervention
Item
previous percutaneous coronary intervention (pci) of the target vessel within 9 months pre-procedure.
boolean
C1532338 (UMLS CUI [1])
percutaneous coronary intervention
Item
planned pci of any vessel within 30 days post-procedure.
boolean
C1532338 (UMLS CUI [1])
other treatment than percutaneous transluminal coronary angioplasty
Item
during the index procedure, the target lesion requires treatment with a device other than ptca prior to stent placement (such as, but not limited to: cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
boolean
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2936173 (UMLS CUI [1,3])
stroke, transient ischemic attack, peptic ulcer, upper gastrointestinal bleeding
Item
history of a stroke or transient ischemic attack within the prior 6 months. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0041909 (UMLS CUI [4])
bleeding diathesis, coagulopathy, blood transfusion
Item
history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
boolean
C0005779 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
life expectancy, concurrent therapy
Item
concurrent medical condition with a life expectancy of less than 12 months. any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to, brachytherapy.
boolean
C0023671 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
study participation status
Item
currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (ivus) or other coronary artery imaging procedures.
boolean
C2348568 (UMLS CUI [1])
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