ID

28756

Beskrivning

Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent; ODM derived from: https://clinicaltrials.gov/show/NCT01308229

Länk

https://clinicaltrials.gov/show/NCT01308229

Nyckelord

Versioner (1)
  1. 2018-02-02 2018-02-02 -
Rättsinnehavare

See clinicaltrials.gov

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2 februari 2018

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Creative Commons BY 4.0
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Eligibility Coronary Disease NCT01308229

Engelsk

Eligibility Coronary Disease NCT01308229

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
de novo bifurcation lesions following the medina classification except (0,0,1).
Beskrivning

Bifurcation lesion of coronary artery de novo Classification | Exception Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0008902
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0008902
maximum one bifurcation lesion per patient.
Beskrivning

Bifurcation lesion of coronary artery Quantity Maximum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
single bifurcation lesion per vessel.
Beskrivning

Bifurcation Lesion Single per Vessel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3640041
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C3887962
UMLS CUI [1,4]
C0005847
the patient is at least 18 years of age. the patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
Beskrivning

Age | Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0151744
UMLS CUI [3]
C0340288
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0340291
UMLS CUI [6,1]
C0039593
UMLS CUI [6,2]
C0205245
UMLS CUI [6,3]
C1514241
the patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergent coronary artery bypass graft (cabg) surgery.
Beskrivning

Patient Appropriate PTCA | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2936173
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C2348535
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0013956
UMLS CUI [3,4]
C0010055
the patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee (irb/ec) of the respective clinical site.
Beskrivning

Protocol Compliance | Protocol Compliance Patient Representative | Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030701
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
the patient agrees to return to the same research facility for all required post-procedure follow-up visits.
Beskrivning

Agreement Follow-up visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0589121
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
de novo bifurcation lesion medina (0,0,1).
Beskrivning

Bifurcation lesion of coronary artery de novo Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0008902
left main bifurcation.
Beskrivning

Left Main Coronary Artery Bifurcation

Datatyp

boolean

Alias
UMLS CUI [1]
C3898614
heavily calcified lesions.
Beskrivning

Lesion Calcified Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
severe tortuous lesions.
Beskrivning

Lesion Tortuous Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C4068863
UMLS CUI [1,3]
C0205082
documented left ventricular ejection fraction (lvef) < 30% at most recent evaluation.
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
women of childbearing potential.
Beskrivning

Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
chronic total occlusion (cto).
Beskrivning

Chronic Total Occlusion

Datatyp

boolean

Alias
UMLS CUI [1]
C3275069
previous pci of the target lesion.
Beskrivning

Percutaneous Coronary Intervention Target Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C2986546
second lesion requiring treatment in target vessel.
Beskrivning

Lesion second Target vessel | Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205436
UMLS CUI [1,3]
C0449618
UMLS CUI [2]
C0332121
second bifurcation lesion requiring treatment.
Beskrivning

Bifurcation lesion of coronary artery second Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C0205436
UMLS CUI [1,3]
C0332121
currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, ivus or other coronary artery imaging procedures.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Incomplete | Interference Endpoints Current | Patient need for Coronary angiography | Patient need for IVUS | Patient need for Coronary artery Imaging

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C0205257
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C2349179
UMLS CUI [5,3]
C0521116
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0085532
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C0206520
UMLS CUI [8,1]
C0686904
UMLS CUI [8,2]
C0205042
UMLS CUI [8,3]
C0011923
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Similar models

Eligibility Coronary Disease NCT01308229

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Bifurcation lesion of coronary artery de novo Classification | Exception Classification
Item
de novo bifurcation lesions following the medina classification except (0,0,1).
boolean
C1299363 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
Bifurcation lesion of coronary artery Quantity Maximum
Item
maximum one bifurcation lesion per patient.
boolean
C1299363 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Bifurcation Lesion Single per Vessel
Item
single bifurcation lesion per vessel.
boolean
C3640041 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C3887962 (UMLS CUI [1,3])
C0005847 (UMLS CUI [1,4])
Age | Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive
Item
the patient is at least 18 years of age. the patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
boolean
C0001779 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
C0340288 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0340291 (UMLS CUI [5])
C0039593 (UMLS CUI [6,1])
C0205245 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
Patient Appropriate PTCA | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery
Item
the patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergent coronary artery bypass graft (cabg) surgery.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2936173 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2348535 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0013956 (UMLS CUI [3,3])
C0010055 (UMLS CUI [3,4])
Protocol Compliance | Protocol Compliance Patient Representative | Informed Consent | Informed Consent Patient Representative
Item
the patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the institutional review board/ethics committee (irb/ec) of the respective clinical site.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Agreement Follow-up visit
Item
the patient agrees to return to the same research facility for all required post-procedure follow-up visits.
boolean
C0680240 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bifurcation lesion of coronary artery de novo Classification
Item
de novo bifurcation lesion medina (0,0,1).
boolean
C1299363 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
Left Main Coronary Artery Bifurcation
Item
left main bifurcation.
boolean
C3898614 (UMLS CUI [1])
Lesion Calcified Severe
Item
heavily calcified lesions.
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Lesion Tortuous Severe
Item
severe tortuous lesions.
boolean
C0221198 (UMLS CUI [1,1])
C4068863 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
documented left ventricular ejection fraction (lvef) < 30% at most recent evaluation.
boolean
C0428772 (UMLS CUI [1])
Childbearing Potential
Item
women of childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Chronic Total Occlusion
Item
chronic total occlusion (cto).
boolean
C3275069 (UMLS CUI [1])
Percutaneous Coronary Intervention Target Lesion
Item
previous pci of the target lesion.
boolean
C1532338 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Lesion second Target vessel | Treatment required for
Item
second lesion requiring treatment in target vessel.
boolean
C0221198 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
C0332121 (UMLS CUI [2])
Bifurcation lesion of coronary artery second Treatment required for
Item
second bifurcation lesion requiring treatment.
boolean
C1299363 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Incomplete | Interference Endpoints Current | Patient need for Coronary angiography | Patient need for IVUS | Patient need for Coronary artery Imaging
Item
currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, ivus or other coronary artery imaging procedures.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C0205257 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C2349179 (UMLS CUI [5,2])
C0521116 (UMLS CUI [5,3])
C0686904 (UMLS CUI [6,1])
C0085532 (UMLS CUI [6,2])
C0686904 (UMLS CUI [7,1])
C0206520 (UMLS CUI [7,2])
C0686904 (UMLS CUI [8,1])
C0205042 (UMLS CUI [8,2])
C0011923 (UMLS CUI [8,3])
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