ID

31005

Beschrijving

A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System; ODM derived from: https://clinicaltrials.gov/show/NCT01151033

Link

https://clinicaltrials.gov/show/NCT01151033

Trefwoorden

Versies (1)
  1. 10-07-18 10-07-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 juli 2018

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Myocardial Ischemia NCT01151033

    Engels

    Eligibility Myocardial Ischemia NCT01151033

    1 Formulieren  
    Criteria
    Beschrijving

    Criteria

    patient must be at least 18 years of age.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the pronova xr des and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site.
    Beschrijving

    Other Coding | Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3846158
    UMLS CUI [2]
    C0021430
    patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia)
    Beschrijving

    Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Function Tests Consistent with Ischemia | ECG change Consistent with Ischemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151744
    UMLS CUI [2]
    C0340288
    UMLS CUI [3]
    C0002965
    UMLS CUI [4]
    C0340291
    UMLS CUI [5,1]
    C0542341
    UMLS CUI [5,2]
    C0392366
    UMLS CUI [5,3]
    C0332290
    UMLS CUI [5,4]
    C0022116
    UMLS CUI [6,1]
    C4062481
    UMLS CUI [6,2]
    C0332290
    UMLS CUI [6,3]
    C0022116
    patient must agree to undergo all required follow-up examinations.
    Beschrijving

    Agreement Follow-up examination

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680240
    UMLS CUI [1,2]
    C0260832
    patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
    Beschrijving

    Childbearing Potential Pregnancy test negative | Breast Feeding Absent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    UMLS CUI [2,1]
    C0006147
    UMLS CUI [2,2]
    C0332197
    angiographic inclusion criteria:
    Beschrijving

    Inclusion criteria Angiography

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0002978
    target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
    Beschrijving

    Target Lesion Identification | Lesion de novo | Previous stent placement Absent | Brachytherapy Previous Absent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2986546
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C1515568
    UMLS CUI [3,1]
    C2114504
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0006098
    UMLS CUI [4,2]
    C0205156
    UMLS CUI [4,3]
    C0332197
    target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
    Beschrijving

    Target vessel Reference Diameter Size

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0449618
    UMLS CUI [1,2]
    C1706462
    UMLS CUI [1,3]
    C1301886
    UMLS CUI [1,4]
    C1444754
    target lesion ≤ 28 mm in length by visual estimate
    Beschrijving

    Target Lesion Length

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2986546
    UMLS CUI [1,2]
    C1444754
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
    Beschrijving

    Comorbidity | Malignant Neoplasms | Congestive heart failure | Substance Use Disorders | Cocaine Abuse | Heroin abuse | Protocol Compliance Absent | Interference Interpretation Research data | Life Expectancy Limited

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0006826
    UMLS CUI [3]
    C0018802
    UMLS CUI [4]
    C0038586
    UMLS CUI [5]
    C0009171
    UMLS CUI [6]
    C0600241
    UMLS CUI [7,1]
    C0525058
    UMLS CUI [7,2]
    C0332197
    UMLS CUI [8,1]
    C0521102
    UMLS CUI [8,2]
    C0459471
    UMLS CUI [8,3]
    C0681873
    UMLS CUI [9,1]
    C0023671
    UMLS CUI [9,2]
    C0439801
    patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
    Beschrijving

    Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Hypersensitivity Bivalirudin | Medical contraindication Bivalirudin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel | Hypersensitivity Ticlopidine | Medical contraindication Ticlopidine | Hypersensitivity Cobalt | Medical contraindication Cobalt | Hypersensitivity Chromium | Medical contraindication Chromium | Allergy to nickel | Medical contraindication Nickel | Contrast media allergy | Premedication Unsuccessful

    Datatype

    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]
    C0070166
    UMLS CUI [8,1]
    C1301624
    UMLS CUI [8,2]
    C0070166
    UMLS CUI [9,1]
    C0020517
    UMLS CUI [9,2]
    C0040207
    UMLS CUI [10,1]
    C1301624
    UMLS CUI [10,2]
    C0040207
    UMLS CUI [11,1]
    C0020517
    UMLS CUI [11,2]
    C0009148
    UMLS CUI [12,1]
    C1301624
    UMLS CUI [12,2]
    C0009148
    UMLS CUI [13,1]
    C0020517
    UMLS CUI [13,2]
    C0008574
    UMLS CUI [14,1]
    C1301624
    UMLS CUI [14,2]
    C0008574
    UMLS CUI [15]
    C1690547
    UMLS CUI [16,1]
    C1301624
    UMLS CUI [16,2]
    C0028013
    UMLS CUI [17]
    C0570562
    UMLS CUI [18,1]
    C0033045
    UMLS CUI [18,2]
    C1272705
    participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
    Beschrijving

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

    Datatype

    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 judged to have a lesion that prevents complete inflation of an angioplasty balloon.
    Beschrijving

    Lesion Preventing Inflation Angioplasty Balloon

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1292733
    UMLS CUI [1,3]
    C1318493
    UMLS CUI [1,4]
    C0002996
    Terug naar het begin van de pagina

    Similar models

    Eligibility Myocardial Ischemia NCT01151033

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Age
    Item
    patient must be at least 18 years of age.
    boolean
    C0001779 (UMLS CUI [1])
    Other Coding | Informed Consent
    Item
    patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the pronova xr des and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site.
    boolean
    C3846158 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Function Tests Consistent with Ischemia | ECG change Consistent with Ischemia
    Item
    patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia)
    boolean
    C0151744 (UMLS CUI [1])
    C0340288 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0340291 (UMLS CUI [4])
    C0542341 (UMLS CUI [5,1])
    C0392366 (UMLS CUI [5,2])
    C0332290 (UMLS CUI [5,3])
    C0022116 (UMLS CUI [5,4])
    C4062481 (UMLS CUI [6,1])
    C0332290 (UMLS CUI [6,2])
    C0022116 (UMLS CUI [6,3])
    Agreement Follow-up examination
    Item
    patient must agree to undergo all required follow-up examinations.
    boolean
    C0680240 (UMLS CUI [1,1])
    C0260832 (UMLS CUI [1,2])
    Childbearing Potential Pregnancy test negative | Breast Feeding Absent
    Item
    patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Inclusion criteria Angiography
    Item
    angiographic inclusion criteria:
    boolean
    C1512693 (UMLS CUI [1,1])
    C0002978 (UMLS CUI [1,2])
    Target Lesion Identification | Lesion de novo | Previous stent placement Absent | Brachytherapy Previous Absent
    Item
    target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
    boolean
    C2986546 (UMLS CUI [1])
    C0221198 (UMLS CUI [2,1])
    C1515568 (UMLS CUI [2,2])
    C2114504 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0006098 (UMLS CUI [4,1])
    C0205156 (UMLS CUI [4,2])
    C0332197 (UMLS CUI [4,3])
    Target vessel Reference Diameter Size
    Item
    target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
    boolean
    C0449618 (UMLS CUI [1,1])
    C1706462 (UMLS CUI [1,2])
    C1301886 (UMLS CUI [1,3])
    C1444754 (UMLS CUI [1,4])
    Target Lesion Length
    Item
    target lesion ≤ 28 mm in length by visual estimate
    boolean
    C2986546 (UMLS CUI [1,1])
    C1444754 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Comorbidity | Malignant Neoplasms | Congestive heart failure | Substance Use Disorders | Cocaine Abuse | Heroin abuse | Protocol Compliance Absent | Interference Interpretation Research data | Life Expectancy Limited
    Item
    patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
    boolean
    C0009488 (UMLS CUI [1])
    C0006826 (UMLS CUI [2])
    C0018802 (UMLS CUI [3])
    C0038586 (UMLS CUI [4])
    C0009171 (UMLS CUI [5])
    C0600241 (UMLS CUI [6])
    C0525058 (UMLS CUI [7,1])
    C0332197 (UMLS CUI [7,2])
    C0521102 (UMLS CUI [8,1])
    C0459471 (UMLS CUI [8,2])
    C0681873 (UMLS CUI [8,3])
    C0023671 (UMLS CUI [9,1])
    C0439801 (UMLS CUI [9,2])
    Aspirin allergy | Medical contraindication Aspirin | Heparin allergy | Medical contraindication Heparin | Hypersensitivity Bivalirudin | Medical contraindication Bivalirudin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel | Hypersensitivity Ticlopidine | Medical contraindication Ticlopidine | Hypersensitivity Cobalt | Medical contraindication Cobalt | Hypersensitivity Chromium | Medical contraindication Chromium | Allergy to nickel | Medical contraindication Nickel | Contrast media allergy | Premedication Unsuccessful
    Item
    patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that 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])
    C0070166 (UMLS CUI [7,2])
    C1301624 (UMLS CUI [8,1])
    C0070166 (UMLS CUI [8,2])
    C0020517 (UMLS CUI [9,1])
    C0040207 (UMLS CUI [9,2])
    C1301624 (UMLS CUI [10,1])
    C0040207 (UMLS CUI [10,2])
    C0020517 (UMLS CUI [11,1])
    C0009148 (UMLS CUI [11,2])
    C1301624 (UMLS CUI [12,1])
    C0009148 (UMLS CUI [12,2])
    C0020517 (UMLS CUI [13,1])
    C0008574 (UMLS CUI [13,2])
    C1301624 (UMLS CUI [14,1])
    C0008574 (UMLS CUI [14,2])
    C1690547 (UMLS CUI [15])
    C1301624 (UMLS CUI [16,1])
    C0028013 (UMLS CUI [16,2])
    C0570562 (UMLS CUI [17])
    C0033045 (UMLS CUI [18,1])
    C1272705 (UMLS CUI [18,2])
    Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Follow-up Completed
    Item
    participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
    boolean
    C2348568 (UMLS CUI [1])
    C2346570 (UMLS CUI [2])
    C0013230 (UMLS CUI [3])
    C3274571 (UMLS CUI [4,1])
    C0205197 (UMLS CUI [4,2])
    Lesion Preventing Inflation Angioplasty Balloon
    Item
    patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
    boolean
    C0221198 (UMLS CUI [1,1])
    C1292733 (UMLS CUI [1,2])
    C1318493 (UMLS CUI [1,3])
    C0002996 (UMLS CUI [1,4])
    Terug naar het begin van de pagina 

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