ID

35533

Beskrivning

H-Side Branch Stent, A New Stent for the Treatment of True Bifurcation Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT02037386

Länk

https://clinicaltrials.gov/show/NCT02037386

Nyckelord

Versioner (1)
  1. 2019-03-07 2019-03-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02037386

Engelsk

Eligibility Coronary Artery Disease NCT02037386

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
older than 20 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
Beskrivning

Angina Pectoris | Ischemic cardiomyopathy Asymptomatic | Requirement Stenting Bifurcation lesion of coronary artery

Datatyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0349782
UMLS CUI [2,2]
C0231221
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C2348535
UMLS CUI [3,3]
C1299363
bifurcation lesion with 2.5~4.0mm of main vessel diameter, <30mm of main vessel length and ≥2.0mm of branched vessel diameter
Beskrivning

Coronary Vessel Bifurcation Lesion | Coronary Vessel Main Diameter | Coronary Vessel Main Length | Coronary Vessel Branched Diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C3640041
UMLS CUI [2,1]
C0010075
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0010075
UMLS CUI [3,2]
C1542147
UMLS CUI [3,3]
C1444754
UMLS CUI [4,1]
C0010075
UMLS CUI [4,2]
C2700384
UMLS CUI [4,3]
C1301886
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute myocardial infarction
Beskrivning

Acute myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0155626
confirmed or suspicious presence of thrombus in target lesion
Beskrivning

Thrombus Target Lesion | Thrombus Target Lesion Suspicious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C2986546
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C2986546
UMLS CUI [2,3]
C0750493
in-stent restenosis lesion
Beskrivning

In Stent restenosis Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3272317
UMLS CUI [1,2]
C0221198
visual angulation with ≥75°
Beskrivning

Angulation Degree

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0333179
UMLS CUI [1,2]
C2348088
lesion with severe calcification or severe tortuosity
Beskrivning

Lesion Calcification Severe | Lesion Tortuosity Severe

Datatyp

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]
C0333076
UMLS CUI [2,3]
C0205082
left main lesion
Beskrivning

Left coronary artery main stem Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0226031
UMLS CUI [1,2]
C0221198
chronic total occlusion lesion
Beskrivning

Chronic total occlusion Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1955779
UMLS CUI [1,2]
C0221198
graft lesion
Beskrivning

Graft Lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C3899021
contraindication to antiplatelet drugs
Beskrivning

Medical contraindication Antiplatelet Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085826
left ventricular dysfunction (lvef ≤40%)
Beskrivning

Ventricular Dysfunction, Left | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2]
C0428772
severe hepatic dysfunction (≥2.5 times than reference of ast or alt)
Beskrivning

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
renal dysfunction (serum creatinine > 2.0mg/dl)
Beskrivning

Renal dysfunction | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
history of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
Beskrivning

Cerebral Hemorrhage | Pulmonary hemorrhage | Gastrointestinal Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C2937358
UMLS CUI [2]
C0151701
UMLS CUI [3]
C0017181
hypersensitivity of aspirin, clopidogrel or contrast media
Beskrivning

Aspirin allergy | Hypersensitivity Clopidogrel | Contrast media allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3]
C0570562
pregnant woman or possibility of pregnancy during clinical study period
Beskrivning

Pregnancy | Possible pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
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Similar models

Eligibility Coronary Artery Disease NCT02037386

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
older than 20 years old
boolean
C0001779 (UMLS CUI [1])
Angina Pectoris | Ischemic cardiomyopathy Asymptomatic | Requirement Stenting Bifurcation lesion of coronary artery
Item
patient with angina or asymptomatic ischemic cardiomyopathy who is required to be treated with stent at coronary bifurcation lesion
boolean
C0002962 (UMLS CUI [1])
C0349782 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C2348535 (UMLS CUI [3,2])
C1299363 (UMLS CUI [3,3])
Coronary Vessel Bifurcation Lesion | Coronary Vessel Main Diameter | Coronary Vessel Main Length | Coronary Vessel Branched Diameter
Item
bifurcation lesion with 2.5~4.0mm of main vessel diameter, <30mm of main vessel length and ≥2.0mm of branched vessel diameter
boolean
C3640041 (UMLS CUI [1])
C0010075 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0010075 (UMLS CUI [3,1])
C1542147 (UMLS CUI [3,2])
C1444754 (UMLS CUI [3,3])
C0010075 (UMLS CUI [4,1])
C2700384 (UMLS CUI [4,2])
C1301886 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Acute myocardial infarction
Item
acute myocardial infarction
boolean
C0155626 (UMLS CUI [1])
Thrombus Target Lesion | Thrombus Target Lesion Suspicious
Item
confirmed or suspicious presence of thrombus in target lesion
boolean
C0087086 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0087086 (UMLS CUI [2,1])
C2986546 (UMLS CUI [2,2])
C0750493 (UMLS CUI [2,3])
In Stent restenosis Lesion
Item
in-stent restenosis lesion
boolean
C3272317 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Angulation Degree
Item
visual angulation with ≥75°
boolean
C0333179 (UMLS CUI [1,1])
C2348088 (UMLS CUI [1,2])
Lesion Calcification Severe | Lesion Tortuosity Severe
Item
lesion with severe calcification or severe tortuosity
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0333076 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Left coronary artery main stem Lesion
Item
left main lesion
boolean
C0226031 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Chronic total occlusion Lesion
Item
chronic total occlusion lesion
boolean
C1955779 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Graft Lesion
Item
graft lesion
boolean
C3899021 (UMLS CUI [1])
Medical contraindication Antiplatelet Agents
Item
contraindication to antiplatelet drugs
boolean
C1301624 (UMLS CUI [1,1])
C0085826 (UMLS CUI [1,2])
Ventricular Dysfunction, Left | Left ventricular ejection fraction
Item
left ventricular dysfunction (lvef ≤40%)
boolean
C0242698 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
severe hepatic dysfunction (≥2.5 times than reference of ast or alt)
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction (serum creatinine > 2.0mg/dl)
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Cerebral Hemorrhage | Pulmonary hemorrhage | Gastrointestinal Hemorrhage
Item
history of cerebral hemorrhage, pulmonary or gastrointestinal bleeding
boolean
C2937358 (UMLS CUI [1])
C0151701 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
Aspirin allergy | Hypersensitivity Clopidogrel | Contrast media allergy
Item
hypersensitivity of aspirin, clopidogrel or contrast media
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0570562 (UMLS CUI [3])
Pregnancy | Possible pregnancy
Item
pregnant woman or possibility of pregnancy during clinical study period
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
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