ID

30076

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00840775

Trefwoorden

Versies (2)
  1. 08-05-18 08-05-18 -
  2. 08-05-18 08-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 mei 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT00840775

Engels

Eligibility Ischemic Heart Disease NCT00840775

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Eligibility Percutaneous Coronary Intervention

Datatype

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.
Beschrijving

Informed Consent

Datatype

boolean

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

Compliance behavior Follow-up Evaluation | Telephone Contact with Patient

Datatype

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.
Beschrijving

Patient Appropriate Coronary Artery Bypass Surgery

Datatype

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).
Beschrijving

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

Datatype

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).
Beschrijving

Gender | Pregnancy Absent | Childbearing Potential Pregnancy test negative

Datatype

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
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

Study Subject Participation Status | Stent Trial

Datatype

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.
Beschrijving

Elective Surgical Procedure Planned | Intervention Percutaneous Planned

Datatype

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.
Beschrijving

Interventional procedure Coronary

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Drug-Eluting Stent Target vessel

Datatype

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
Beschrijving

Drug-Eluting Stent

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Comorbidity | Life Expectancy

Datatype

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.
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 | Allergy to nickel | Medical contraindication Nickel | Hypersensitivity Cobalt-Chromium Alloy | Medical contraindication Cobalt-Chromium Alloy | 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]
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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Similar models

Eligibility Ischemic Heart Disease NCT00840775

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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