ID

35578

Descrição

Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study; ODM derived from: https://clinicaltrials.gov/show/NCT02419521

Link

https://clinicaltrials.gov/show/NCT02419521

Palavras-chave

Versões (1)
  1. 10/03/2019 10/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02419521

Inglês

Eligibility Coronary Artery Disease NCT02419521

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be an acceptable candidate for percutaneous coronary intervention (pci), stenting, and emergent coronary artery bypass graft (cabg) surgery
Descrição

Patient Acceptable Percutaneous Coronary Intervention | Patient Acceptable Stenting | Patient Acceptable Emergency CABG

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1879533
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1879533
UMLS CUI [2,3]
C2348535
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1879533
UMLS CUI [3,3]
C1532296
must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
Descrição

Myocardial Ischemia | Stable angina | Angina, Unstable | Heart Function Test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0018803
UMLS CUI [4,2]
C1514241
must require treatment of either a) a single target lesion amenable to treatment or b) two target lesions located in separate target vessels
Descrição

Target Lesion Single Amenable Treatment | Target Lesion Quantity | Location Target vessel Separate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0449618
UMLS CUI [3,3]
C0443299
target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Descrição

Target Lesion de novo | Location Coronary artery Native

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205042
UMLS CUI [2,3]
C0302891
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
Descrição

Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Hypersensitivity Bivalirudin | Medical contraindication Bivalirudin | Hypersensitivity Thienopyridines | Medical contraindication Thienopyridines | Hypersensitivity Cobalt | Medical contraindication Cobalt | Allergy to nickel | Medical contraindication Nickel | Hypersensitivity Platinum | Medical contraindication Platinum | Hypersensitivity Iridium | Medical contraindication Iridium | Hypersensitivity Chromium | Medical contraindication Chromium | Hypersensitivity Molybdenum | Medical contraindication Molybdenum | Hypersensitivity Polymers Coating | Medical contraindication Polymers Coating | Contrast media allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0004057
UMLS CUI [3]
C0571776
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0019134
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0168273
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0168273
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C2936588
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C2936588
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0009148
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0009148
UMLS CUI [11]
C1690547
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C0028013
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C0032207
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C0032207
UMLS CUI [15,1]
C0020517
UMLS CUI [15,2]
C0022071
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C0022071
UMLS CUI [17,1]
C0020517
UMLS CUI [17,2]
C0008574
UMLS CUI [18,1]
C1301624
UMLS CUI [18,2]
C0008574
UMLS CUI [19,1]
C0020517
UMLS CUI [19,2]
C0026402
UMLS CUI [20,1]
C1301624
UMLS CUI [20,2]
C0026402
UMLS CUI [21,1]
C0020517
UMLS CUI [21,2]
C0032521
UMLS CUI [21,3]
C1522408
UMLS CUI [22,1]
C1301624
UMLS CUI [22,2]
C0032521
UMLS CUI [22,3]
C1522408
UMLS CUI [23]
C0570562
history of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
Descrição

Allergic Reaction Zotarolimus | Hypersensitivity Zotarolimus | Allergic Reaction Sirolimus | Hypersensitivity Sirolimus | Allergic Reaction Tacrolimus | Hypersensitivity Tacrolimus | Allergic Reaction Everolimus | Hypersensitivity Everolimus | Allergic Reaction Analogue Any | Hypersensitivity Analogue Any | Allergic Reaction Derivative Any | Hypersensitivity Derivative Any

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1700035
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1700035
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0072980
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0085149
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0085149
UMLS CUI [7,1]
C1527304
UMLS CUI [7,2]
C0541315
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0541315
UMLS CUI [9,1]
C1527304
UMLS CUI [9,2]
C0243071
UMLS CUI [9,3]
C1552551
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0243071
UMLS CUI [10,3]
C1552551
UMLS CUI [11,1]
C1527304
UMLS CUI [11,2]
C1527240
UMLS CUI [11,3]
C1552551
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C1527240
UMLS CUI [12,3]
C1552551
history of a stroke or transient ischemic attack (tia) within the prior 6 months
Descrição

Cerebrovascular accident | Transient Ischemic Attack

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
Descrição

Peptic Ulcer | Upper gastrointestinal hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Descrição

Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Refused

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0005841
UMLS CUI [3,2]
C1705116
concurrent medical condition with a life expectancy of less than 12 months
Descrição

Comorbidity | Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
currently participating in an investigational drug or another device trial that has not completed the primary endpoint
Descrição

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | End Point Primary Incomplete

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2349179
UMLS CUI [4,2]
C0205225
UMLS CUI [4,3]
C0205257
documented left ventricular ejection fraction (lvef) < 30% at the most recent evaluation
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Coronary Artery Disease NCT02419521

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Patient Acceptable Percutaneous Coronary Intervention | Patient Acceptable Stenting | Patient Acceptable Emergency CABG
Item
must be an acceptable candidate for percutaneous coronary intervention (pci), stenting, and emergent coronary artery bypass graft (cabg) surgery
boolean
C0030705 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C2348535 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
C1532296 (UMLS CUI [3,3])
Myocardial Ischemia | Stable angina | Angina, Unstable | Heart Function Test Positive
Item
must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018803 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Target Lesion Single Amenable Treatment | Target Lesion Quantity | Location Target vessel Separate
Item
must require treatment of either a) a single target lesion amenable to treatment or b) two target lesions located in separate target vessels
boolean
C2986546 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C2986546 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C0449618 (UMLS CUI [3,2])
C0443299 (UMLS CUI [3,3])
Target Lesion de novo | Location Coronary artery Native
Item
target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
boolean
C2986546 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205042 (UMLS CUI [2,2])
C0302891 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Hypersensitivity Bivalirudin | Medical contraindication Bivalirudin | Hypersensitivity Thienopyridines | Medical contraindication Thienopyridines | Hypersensitivity Cobalt | Medical contraindication Cobalt | Allergy to nickel | Medical contraindication Nickel | Hypersensitivity Platinum | Medical contraindication Platinum | Hypersensitivity Iridium | Medical contraindication Iridium | Hypersensitivity Chromium | Medical contraindication Chromium | Hypersensitivity Molybdenum | Medical contraindication Molybdenum | Hypersensitivity Polymers Coating | Medical contraindication Polymers Coating | Contrast media allergy
Item
known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
boolean
C0004058 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0571776 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0168273 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0168273 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C2936588 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C2936588 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0009148 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0009148 (UMLS CUI [10,2])
C1690547 (UMLS CUI [11])
C1301624 (UMLS CUI [12,1])
C0028013 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0032207 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C0032207 (UMLS CUI [14,2])
C0020517 (UMLS CUI [15,1])
C0022071 (UMLS CUI [15,2])
C1301624 (UMLS CUI [16,1])
C0022071 (UMLS CUI [16,2])
C0020517 (UMLS CUI [17,1])
C0008574 (UMLS CUI [17,2])
C1301624 (UMLS CUI [18,1])
C0008574 (UMLS CUI [18,2])
C0020517 (UMLS CUI [19,1])
C0026402 (UMLS CUI [19,2])
C1301624 (UMLS CUI [20,1])
C0026402 (UMLS CUI [20,2])
C0020517 (UMLS CUI [21,1])
C0032521 (UMLS CUI [21,2])
C1522408 (UMLS CUI [21,3])
C1301624 (UMLS CUI [22,1])
C0032521 (UMLS CUI [22,2])
C1522408 (UMLS CUI [22,3])
C0570562 (UMLS CUI [23])
Allergic Reaction Zotarolimus | Hypersensitivity Zotarolimus | Allergic Reaction Sirolimus | Hypersensitivity Sirolimus | Allergic Reaction Tacrolimus | Hypersensitivity Tacrolimus | Allergic Reaction Everolimus | Hypersensitivity Everolimus | Allergic Reaction Analogue Any | Hypersensitivity Analogue Any | Allergic Reaction Derivative Any | Hypersensitivity Derivative Any
Item
history of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
boolean
C1527304 (UMLS CUI [1,1])
C1700035 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1700035 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0072980 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0085149 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0085149 (UMLS CUI [6,2])
C1527304 (UMLS CUI [7,1])
C0541315 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0541315 (UMLS CUI [8,2])
C1527304 (UMLS CUI [9,1])
C0243071 (UMLS CUI [9,2])
C1552551 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0243071 (UMLS CUI [10,2])
C1552551 (UMLS CUI [10,3])
C1527304 (UMLS CUI [11,1])
C1527240 (UMLS CUI [11,2])
C1552551 (UMLS CUI [11,3])
C0020517 (UMLS CUI [12,1])
C1527240 (UMLS CUI [12,2])
C1552551 (UMLS CUI [12,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of a stroke or transient ischemic attack (tia) within the prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Peptic Ulcer | Upper gastrointestinal hemorrhage
Item
active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
Bleeding tendency | Blood Coagulation Disorders | Blood Transfusion Refused
Item
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0005841 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Comorbidity | Life Expectancy
Item
concurrent medical condition with a life expectancy of less than 12 months
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | End Point Primary Incomplete
Item
currently participating in an investigational drug or another device trial that has not completed the primary endpoint
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2349179 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) < 30% at the most recent evaluation
boolean
C0428772 (UMLS CUI [1])
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