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ID

28754

Description

ProStent Coronary Drug-Eluting Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00887211

Link

https://clinicaltrials.gov/show/NCT00887211

Keywords

Versions (1)
  1. 2/1/18 2/1/18 -
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See clinicaltrials.gov

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February 1, 2018

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Creative Commons BY 4.0
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    Eligibility Coronary Disease NCT00887211

    English

    Eligibility Coronary Disease NCT00887211

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 18-75 years, men or unpregnant women;
    Description

    Age | Gender | Pregnancy Absent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0079399
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C0332197
    2. angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
    Description

    Angina Pectoris | Myocardial Ischemia Asymptomatic | Myocardial Infarction obsolete

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002962
    UMLS CUI [2,1]
    C0151744
    UMLS CUI [2,2]
    C0231221
    UMLS CUI [3,1]
    C0027051
    UMLS CUI [3,2]
    C0521120
    3. total of lesion artery ≤2;
    Description

    Lesion Artery Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0003842
    UMLS CUI [1,3]
    C1265611
    4. lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
    Description

    Lesion Artery Length Diameter

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0003842
    UMLS CUI [1,3]
    C1444754
    UMLS CUI [1,4]
    C1301886
    5. narrow level of lesion artery ≥70% in diameter (ocular estimate);
    Description

    Lesion Artery Percentage Diameter

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0003842
    UMLS CUI [1,3]
    C0439165
    UMLS CUI [1,4]
    C1301886
    6. amount of same stents implanted in a lesion artery ≤2;
    Description

    Placement of stent Quantity Lesion Artery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0522776
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [1,3]
    C0221198
    UMLS CUI [1,4]
    C0003842
    7. patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
    Description

    Indication Coronary Artery Bypass Surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0010055
    8. patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept fellow-up
    Description

    Informed Consent | Follow-up Willing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C3274571
    UMLS CUI [2,2]
    C0600109
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients with acute myocardial infarction in recent one month;
    Description

    Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    2. chronic total occlusion lesions(timi 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.5mm;
    Description

    Chronic Total Occlusion Lesion | TIMI Flow Grade | Trunk of left coronary artery Lesion | Lesion Branch Quantity Treatment required for | Coronary Vessel Bifurcation Lesion | Other Coding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3275069
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [2,1]
    C3272266
    UMLS CUI [2,2]
    C4263591
    UMLS CUI [3,1]
    C0920980
    UMLS CUI [3,2]
    C0221198
    UMLS CUI [4,1]
    C0221198
    UMLS CUI [4,2]
    C1253959
    UMLS CUI [4,3]
    C1265611
    UMLS CUI [4,4]
    C0332121
    UMLS CUI [5]
    C3640041
    UMLS CUI [6]
    C3846158
    3. severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
    Description

    Lesion Calcific Severe | Lesion Twisted | Lesion Inappropriate Stent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0175895
    UMLS CUI [1,3]
    C0205082
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0231467
    UMLS CUI [3,1]
    C0221198
    UMLS CUI [3,2]
    C1548788
    UMLS CUI [3,3]
    C0038257
    4. in-stent restenosis lesions;
    Description

    In Stent restenosis Lesion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3272317
    UMLS CUI [1,2]
    C0221198
    5. patients with stent implantation in his/her coronary artery within recent one year;
    Description

    Placement of stent in coronary artery

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521232
    6. severs heart failure(over nyha iii grade ), or left ventricular ejection fraction(lvef)< 40%( supersonic inspection or left ventricular radiography );
    Description

    Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction Left ventricle Radiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C1275491
    UMLS CUI [2,1]
    C0428772
    UMLS CUI [2,2]
    C0225897
    UMLS CUI [2,3]
    C0034571
    7. kidney functional damage prior to implantation, serum creatinine level＞2.0mg/dl;
    Description

    Kidney function impaired prior to Implantation | Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0184571
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0021107
    UMLS CUI [2]
    C0201976
    8. patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
    Description

    Bleeding tendency | Digestive ulcer | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Cerebral apoplexy | Medical contraindication Platelet Inhibitors | Medical contraindication Anticoagulants | Patients Inappropriate Anticoagulation Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1458140
    UMLS CUI [2]
    C0237938
    UMLS CUI [3]
    C2937358
    UMLS CUI [4]
    C0038525
    UMLS CUI [5]
    C0038454
    UMLS CUI [6,1]
    C1301624
    UMLS CUI [6,2]
    C0032188
    UMLS CUI [7,1]
    C1301624
    UMLS CUI [7,2]
    C0003280
    UMLS CUI [8,1]
    C0030705
    UMLS CUI [8,2]
    C1548788
    UMLS CUI [8,3]
    C0003281
    9. patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
    Description

    Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Heparin allergy | Contrast media allergy | Hypersensitivity Rapamycin | Metal allergy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004058
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0070166
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0040207
    UMLS CUI [4]
    C0571776
    UMLS CUI [5]
    C0570562
    UMLS CUI [6,1]
    C0020517
    UMLS CUI [6,2]
    C0072980
    UMLS CUI [7]
    C0577627
    10. patients whose life expectancy less than 12 months;
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    11. patients who are participating in other drugs or medical devices clinical trials;
    Description

    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    UMLS CUI [3]
    C2346570
    12. patients who can not comply with the clinical trial protocol;
    Description

    Protocol Compliance Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    13. patients having a heart transplant.
    Description

    Heart Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018823
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    Similar models

    Eligibility Coronary Disease NCT00887211

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Gender | Pregnancy Absent
    Item
    1. age 18-75 years, men or unpregnant women;
    boolean
    C0001779 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0032961 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Angina Pectoris | Myocardial Ischemia Asymptomatic | Myocardial Infarction obsolete
    Item
    2. angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
    boolean
    C0002962 (UMLS CUI [1])
    C0151744 (UMLS CUI [2,1])
    C0231221 (UMLS CUI [2,2])
    C0027051 (UMLS CUI [3,1])
    C0521120 (UMLS CUI [3,2])
    Lesion Artery Quantity
    Item
    3. total of lesion artery ≤2;
    boolean
    C0221198 (UMLS CUI [1,1])
    C0003842 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Lesion Artery Length Diameter
    Item
    4. lesion artery ≤30 mm in length, 2.5 to 4.0 mm in diameter (ocular estimate);
    boolean
    C0221198 (UMLS CUI [1,1])
    C0003842 (UMLS CUI [1,2])
    C1444754 (UMLS CUI [1,3])
    C1301886 (UMLS CUI [1,4])
    Lesion Artery Percentage Diameter
    Item
    5. narrow level of lesion artery ≥70% in diameter (ocular estimate);
    boolean
    C0221198 (UMLS CUI [1,1])
    C0003842 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [1,3])
    C1301886 (UMLS CUI [1,4])
    Placement of stent Quantity Lesion Artery
    Item
    6. amount of same stents implanted in a lesion artery ≤2;
    boolean
    C0522776 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [1,3])
    C0003842 (UMLS CUI [1,4])
    Indication Coronary Artery Bypass Surgery
    Item
    7. patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
    boolean
    C3146298 (UMLS CUI [1,1])
    C0010055 (UMLS CUI [1,2])
    Informed Consent | Follow-up Willing
    Item
    8. patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept fellow-up
    boolean
    C0021430 (UMLS CUI [1])
    C3274571 (UMLS CUI [2,1])
    C0600109 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    Myocardial Infarction
    Item
    1. patients with acute myocardial infarction in recent one month;
    boolean
    C0027051 (UMLS CUI [1])
    Chronic Total Occlusion Lesion | TIMI Flow Grade | Trunk of left coronary artery Lesion | Lesion Branch Quantity Treatment required for | Coronary Vessel Bifurcation Lesion | Other Coding
    Item
    2. chronic total occlusion lesions(timi 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.5mm;
    boolean
    C3275069 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C3272266 (UMLS CUI [2,1])
    C4263591 (UMLS CUI [2,2])
    C0920980 (UMLS CUI [3,1])
    C0221198 (UMLS CUI [3,2])
    C0221198 (UMLS CUI [4,1])
    C1253959 (UMLS CUI [4,2])
    C1265611 (UMLS CUI [4,3])
    C0332121 (UMLS CUI [4,4])
    C3640041 (UMLS CUI [5])
    C3846158 (UMLS CUI [6])
    Lesion Calcific Severe | Lesion Twisted | Lesion Inappropriate Stent
    Item
    3. severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
    boolean
    C0221198 (UMLS CUI [1,1])
    C0175895 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    C0221198 (UMLS CUI [2,1])
    C0231467 (UMLS CUI [2,2])
    C0221198 (UMLS CUI [3,1])
    C1548788 (UMLS CUI [3,2])
    C0038257 (UMLS CUI [3,3])
    In Stent restenosis Lesion
    Item
    4. in-stent restenosis lesions;
    boolean
    C3272317 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Placement of stent in coronary artery
    Item
    5. patients with stent implantation in his/her coronary artery within recent one year;
    boolean
    C0521232 (UMLS CUI [1])
    Heart failure Severe New York Heart Association Classification | Left ventricular ejection fraction Left ventricle Radiography
    Item
    6. severs heart failure(over nyha iii grade ), or left ventricular ejection fraction(lvef)< 40%( supersonic inspection or left ventricular radiography );
    boolean
    C0018801 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [1,3])
    C0428772 (UMLS CUI [2,1])
    C0225897 (UMLS CUI [2,2])
    C0034571 (UMLS CUI [2,3])
    Kidney function impaired prior to Implantation | Creatinine measurement, serum
    Item
    7. kidney functional damage prior to implantation, serum creatinine level＞2.0mg/dl;
    boolean
    C0184571 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0021107 (UMLS CUI [1,3])
    C0201976 (UMLS CUI [2])
    Bleeding tendency | Digestive ulcer | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Cerebral apoplexy | Medical contraindication Platelet Inhibitors | Medical contraindication Anticoagulants | Patients Inappropriate Anticoagulation Therapy
    Item
    8. patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
    boolean
    C1458140 (UMLS CUI [1])
    C0237938 (UMLS CUI [2])
    C2937358 (UMLS CUI [3])
    C0038525 (UMLS CUI [4])
    C0038454 (UMLS CUI [5])
    C1301624 (UMLS CUI [6,1])
    C0032188 (UMLS CUI [6,2])
    C1301624 (UMLS CUI [7,1])
    C0003280 (UMLS CUI [7,2])
    C0030705 (UMLS CUI [8,1])
    C1548788 (UMLS CUI [8,2])
    C0003281 (UMLS CUI [8,3])
    Aspirin allergy | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Heparin allergy | Contrast media allergy | Hypersensitivity Rapamycin | Metal allergy
    Item
    9. patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
    boolean
    C0004058 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0070166 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0040207 (UMLS CUI [3,2])
    C0571776 (UMLS CUI [4])
    C0570562 (UMLS CUI [5])
    C0020517 (UMLS CUI [6,1])
    C0072980 (UMLS CUI [6,2])
    C0577627 (UMLS CUI [7])
    Life Expectancy
    Item
    10. patients whose life expectancy less than 12 months;
    boolean
    C0023671 (UMLS CUI [1])
    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
    Item
    11. patients who are participating in other drugs or medical devices clinical trials;
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C2346570 (UMLS CUI [3])
    Protocol Compliance Unable
    Item
    12. patients who can not comply with the clinical trial protocol;
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Heart Transplantation
    Item
    13. patients having a heart transplant.
    boolean
    C0018823 (UMLS CUI [1])
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