ID

30076

Description

PIONIR Study (Presillion™ and Presillion™ Plus Stent Systems); ODM derived from: https://clinicaltrials.gov/show/NCT00840775

Link

https://clinicaltrials.gov/show/NCT00840775

Keywords

Versions (2)
  1. 5/8/18 5/8/18 -
  2. 5/8/18 5/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 8, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Ischemic Heart Disease NCT00840775

    English

    Eligibility Ischemic Heart Disease NCT00840775

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patient >= 18 years old.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. eligible for percutaneous coronary intervention (pci).
    Description

    Eligibility Percutaneous Coronary Intervention

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1548635
    UMLS CUI [1,2]
    C1532338
    3. patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    4. patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
    Description

    Compliance behavior Follow-up Evaluation | Telephone Contact with Patient

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C3274571
    UMLS CUI [1,3]
    C1261322
    UMLS CUI [2,1]
    C0039457
    UMLS CUI [2,2]
    C0332158
    UMLS CUI [2,3]
    C0030705
    5. acceptable candidate for coronary artery bypass graft (cabg) surgery.
    Description

    Patient Appropriate Coronary Artery Bypass Surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548787
    UMLS CUI [1,3]
    C0010055
    6. stable angina pectoris (canadian cardiovascular society (ccs) 1, 2, 3 or 4) or unstable angina pectoris (braunwald class 1-3, b-c) or a positive functional ischemia study (e.g., ett, spect, stress echocardiography or cardiac ct).
    Description

    Stable angina CCS Grading Scale Class | Unstable Angina Class | Ischemia Test Functional Positive | Exercise Treadmill Test | SPECT | Echocardiography, Stress | Cardiac CT

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0340288
    UMLS CUI [1,2]
    C1879987
    UMLS CUI [2,1]
    C0002965
    UMLS CUI [2,2]
    C0456387
    UMLS CUI [3,1]
    C0022116
    UMLS CUI [3,2]
    C0039593
    UMLS CUI [3,3]
    C0205245
    UMLS CUI [3,4]
    C1514241
    UMLS CUI [4,1]
    C0015259
    UMLS CUI [4,2]
    C0087110
    UMLS CUI [5]
    C0040399
    UMLS CUI [6]
    C0920208
    UMLS CUI [7]
    C0412618
    7. male or non-pregnant female patient (note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
    Description

    Gender | Pregnancy Absent | Childbearing Potential Pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0427780
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
    Description

    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Trial Interferes with Endpoints

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    UMLS CUI [3]
    C2346570
    UMLS CUI [4,1]
    C0008976
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C2349179
    2. previously enrolled in another stent trial in the previous 2 years.
    Description

    Study Subject Participation Status | Stent Trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C0038257
    UMLS CUI [2,2]
    C0008976
    3. any planned elective surgery or percutaneous intervention within subsequent 9 months.
    Description

    Elective Surgical Procedure Planned | Intervention Percutaneous Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0206058
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [2,1]
    C0184661
    UMLS CUI [2,2]
    C0522523
    UMLS CUI [2,3]
    C1301732
    4. a previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
    Description

    Interventional procedure Coronary

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0184661
    UMLS CUI [1,2]
    C1522318
    5. the subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
    Description

    Patient need for Staged operation | Procedure Target vessel | Procedure Blood Vessel Except Target vessel

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0686904
    UMLS CUI [1,2]
    C4027584
    UMLS CUI [2,1]
    C0184661
    UMLS CUI [2,2]
    C0449618
    UMLS CUI [3,1]
    C0184661
    UMLS CUI [3,2]
    C0005847
    UMLS CUI [3,3]
    C0332300
    UMLS CUI [3,4]
    C0449618
    6. previous drug eluting stent (des) deployment anywhere in the target vessel.
    Description

    Drug-Eluting Stent Target vessel

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1322815
    UMLS CUI [1,2]
    C0449618
    7. any drug eluting stent (des) deployment anywhere within the past 12 months
    Description

    Drug-Eluting Stent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1322815
    8. co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
    Description

    Comorbidity Study Subject Participation Status Limited | Comorbidity Protocol Compliance Limited | Comorbidity Impact Integrity Clinical Trial

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0439801
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0525058
    UMLS CUI [2,3]
    C0439801
    UMLS CUI [3,1]
    C0009488
    UMLS CUI [3,2]
    C4049986
    UMLS CUI [3,3]
    C1947912
    UMLS CUI [3,4]
    C0008976
    9. concurrent medical condition with a life expectancy of less than 12 months.
    Description

    Comorbidity | Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C0023671
    10. known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, l-605 cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
    Description

    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 | Allergy to nickel | Medical contraindication Nickel | Hypersensitivity Cobalt-Chromium Alloy | Medical contraindication Cobalt-Chromium Alloy | Contrast media allergy | Premedication Unsuccessful

    Data type

    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]
    C1690547
    UMLS CUI [14,1]
    C1301624
    UMLS CUI [14,2]
    C0028013
    UMLS CUI [15,1]
    C0020517
    UMLS CUI [15,2]
    C0008576
    UMLS CUI [16,1]
    C1301624
    UMLS CUI [16,2]
    C0008576
    UMLS CUI [17]
    C0570562
    UMLS CUI [18,1]
    C0033045
    UMLS CUI [18,2]
    C1272705
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    Eligibility Ischemic Heart Disease NCT00840775

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. patient >= 18 years old.
    boolean
    C0001779 (UMLS CUI [1])
    Eligibility Percutaneous Coronary Intervention
    Item
    2. eligible for percutaneous coronary intervention (pci).
    boolean
    C1548635 (UMLS CUI [1,1])
    C1532338 (UMLS CUI [1,2])
    Informed Consent
    Item
    3. patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
    boolean
    C0021430 (UMLS CUI [1])
    Compliance behavior Follow-up Evaluation | Telephone Contact with Patient
    Item
    4. patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
    boolean
    C1321605 (UMLS CUI [1,1])
    C3274571 (UMLS CUI [1,2])
    C1261322 (UMLS CUI [1,3])
    C0039457 (UMLS CUI [2,1])
    C0332158 (UMLS CUI [2,2])
    C0030705 (UMLS CUI [2,3])
    Patient Appropriate Coronary Artery Bypass Surgery
    Item
    5. acceptable candidate for coronary artery bypass graft (cabg) surgery.
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548787 (UMLS CUI [1,2])
    C0010055 (UMLS CUI [1,3])
    Stable angina CCS Grading Scale Class | Unstable Angina Class | Ischemia Test Functional Positive | Exercise Treadmill Test | SPECT | Echocardiography, Stress | Cardiac CT
    Item
    6. stable angina pectoris (canadian cardiovascular society (ccs) 1, 2, 3 or 4) or unstable angina pectoris (braunwald class 1-3, b-c) or a positive functional ischemia study (e.g., ett, spect, stress echocardiography or cardiac ct).
    boolean
    C0340288 (UMLS CUI [1,1])
    C1879987 (UMLS CUI [1,2])
    C0002965 (UMLS CUI [2,1])
    C0456387 (UMLS CUI [2,2])
    C0022116 (UMLS CUI [3,1])
    C0039593 (UMLS CUI [3,2])
    C0205245 (UMLS CUI [3,3])
    C1514241 (UMLS CUI [3,4])
    C0015259 (UMLS CUI [4,1])
    C0087110 (UMLS CUI [4,2])
    C0040399 (UMLS CUI [5])
    C0920208 (UMLS CUI [6])
    C0412618 (UMLS CUI [7])
    Gender | Pregnancy Absent | Childbearing Potential Pregnancy test negative
    Item
    7. male or non-pregnant female patient (note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
    boolean
    C0079399 (UMLS CUI [1])
    C0032961 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C3831118 (UMLS CUI [3,1])
    C0427780 (UMLS CUI [3,2])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Trial Interferes with Endpoints
    Item
    1. currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C2346570 (UMLS CUI [3])
    C0008976 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C2349179 (UMLS CUI [4,3])
    Study Subject Participation Status | Stent Trial
    Item
    2. previously enrolled in another stent trial in the previous 2 years.
    boolean
    C2348568 (UMLS CUI [1])
    C0038257 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    Elective Surgical Procedure Planned | Intervention Percutaneous Planned
    Item
    3. any planned elective surgery or percutaneous intervention within subsequent 9 months.
    boolean
    C0206058 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [2,1])
    C0522523 (UMLS CUI [2,2])
    C1301732 (UMLS CUI [2,3])
    Interventional procedure Coronary
    Item
    4. a previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
    boolean
    C0184661 (UMLS CUI [1,1])
    C1522318 (UMLS CUI [1,2])
    Patient need for Staged operation | Procedure Target vessel | Procedure Blood Vessel Except Target vessel
    Item
    5. the subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
    boolean
    C0686904 (UMLS CUI [1,1])
    C4027584 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [2,1])
    C0449618 (UMLS CUI [2,2])
    C0184661 (UMLS CUI [3,1])
    C0005847 (UMLS CUI [3,2])
    C0332300 (UMLS CUI [3,3])
    C0449618 (UMLS CUI [3,4])
    Drug-Eluting Stent Target vessel
    Item
    6. previous drug eluting stent (des) deployment anywhere in the target vessel.
    boolean
    C1322815 (UMLS CUI [1,1])
    C0449618 (UMLS CUI [1,2])
    Drug-Eluting Stent
    Item
    7. any drug eluting stent (des) deployment anywhere within the past 12 months
    boolean
    C1322815 (UMLS CUI [1])
    Comorbidity Study Subject Participation Status Limited | Comorbidity Protocol Compliance Limited | Comorbidity Impact Integrity Clinical Trial
    Item
    8. co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
    boolean
    C0009488 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C0525058 (UMLS CUI [2,2])
    C0439801 (UMLS CUI [2,3])
    C0009488 (UMLS CUI [3,1])
    C4049986 (UMLS CUI [3,2])
    C1947912 (UMLS CUI [3,3])
    C0008976 (UMLS CUI [3,4])
    Comorbidity | Life Expectancy
    Item
    9. concurrent medical condition with a life expectancy of less than 12 months.
    boolean
    C0009488 (UMLS CUI [1])
    C0023671 (UMLS CUI [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 | Allergy to nickel | Medical contraindication Nickel | Hypersensitivity Cobalt-Chromium Alloy | Medical contraindication Cobalt-Chromium Alloy | Contrast media allergy | Premedication Unsuccessful
    Item
    10. known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, l-605 cobalt chromium alloy or 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])
    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])
    C1690547 (UMLS CUI [13])
    C1301624 (UMLS CUI [14,1])
    C0028013 (UMLS CUI [14,2])
    C0020517 (UMLS CUI [15,1])
    C0008576 (UMLS CUI [15,2])
    C1301624 (UMLS CUI [16,1])
    C0008576 (UMLS CUI [16,2])
    C0570562 (UMLS CUI [17])
    C0033045 (UMLS CUI [18,1])
    C1272705 (UMLS CUI [18,2])
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