ID

31005

Description

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

Keywords

Versions (1)
  1. 7/10/18 7/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Myocardial Ischemia NCT01151033

English

Eligibility Myocardial Ischemia NCT01151033

1 forms  
Criteria
Description

Criteria

patient must be at least 18 years of age.
Description

Age

Data type

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.
Description

Other Coding | Informed Consent

Data type

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)
Description

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

Data type

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.
Description

Agreement Follow-up examination

Data type

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.
Description

Childbearing Potential Pregnancy test negative | Breast Feeding Absent

Data type

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:
Description

Inclusion criteria Angiography

Data type

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)
Description

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

Data type

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
Description

Target vessel Reference Diameter Size

Data type

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
Description

Target Lesion Length

Data type

boolean

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

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)
Description

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

Data type

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
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 | Hypersensitivity Chromium | Medical contraindication Chromium | Allergy to nickel | Medical contraindication Nickel | 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 [13,1]
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
Description

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

Data type

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.
Description

Lesion Preventing Inflation Angioplasty Balloon

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1318493
UMLS CUI [1,4]
C0002996
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Similar models

Eligibility Myocardial Ischemia NCT01151033

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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