ID

15034

Description

The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.; ODM derived from: https://clinicaltrials.gov/show/NCT00381420

Link

https://clinicaltrials.gov/show/NCT00381420

Keywords

Versions (1)
  1. 5/12/16 5/12/16 -
Uploaded on

May 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00381420

English

Eligibility Coronary Artery Disease NCT00381420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii) or patients with documented silent ischemia;
Description

Angina pectoris or unstable angina pectoris or silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0002965
UMLS CUI [1,3]
C0340291
single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
Description

Coronary Artery Stenosis Lesions: localisation, Number, de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C0449791
UMLS CUI [1,2]
C0475264
UMLS CUI [1,3]
C0242231
UMLS CUI [1,4]
C1515568
target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
Description

coronary artery diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0456389
target lesion is >=15mm and <=32mm in length (visual estimate);
Description

Lesion size

Data type

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0010068
target lesion stenosis is >50% and <100% (visual estimate);
Description

severity of coronary stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439793
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment;
Description

myocardial infarction severity by ecg and ck (ckmb)

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C1623258
UMLS CUI [1,4]
C0201973
has unstable angina classified as braunwald iii b or c and a i-ii-iii, or is having a peri infarction;
Description

Unstable angina or Peri Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0027051
unprotected left main coronary disease with >=50% stenosis;
Description

Localisation and severity of coronary stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C0475264
significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Description

Coronary Stenosis additional lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0242231
have an ostial target lesion;
Description

Coronary Stenosis at Ostium

Data type

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0475264
angiographic evidence of thrombus within target lesion;
Description

Thrombus

Data type

boolean

Alias
UMLS CUI [1]
C0087086
heavily calcified lesion which cannot be successfully predilated;
Description

Heavy Calcification

Data type

boolean

Alias
UMLS CUI [1,1]
C1533591
UMLS CUI [1,2]
C0012356
documented left ventricular ejection fraction <=25%.
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Coronary Artery Disease NCT00381420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Angina pectoris or unstable angina pectoris or silent myocardial ischemia
Item
diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b&c, i-ii) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0340291 (UMLS CUI [1,3])
Coronary Artery Stenosis Lesions: localisation, Number, de novo
Item
single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
boolean
C0449791 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0242231 (UMLS CUI [1,3])
C1515568 (UMLS CUI [1,4])
coronary artery diameter
Item
target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
boolean
C0205042 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Lesion size
Item
target lesion is >=15mm and <=32mm in length (visual estimate);
boolean
C0449453 (UMLS CUI [1,1])
C0010068 (UMLS CUI [1,2])
severity of coronary stenosis
Item
target lesion stenosis is >50% and <100% (visual estimate);
boolean
C0242231 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
myocardial infarction severity by ecg and ck (ckmb)
Item
patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck >2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment;
boolean
C0027051 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0201973 (UMLS CUI [1,4])
Unstable angina or Peri Infarction
Item
has unstable angina classified as braunwald iii b or c and a i-ii-iii, or is having a peri infarction;
boolean
C0002965 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Localisation and severity of coronary stenosis
Item
unprotected left main coronary disease with >=50% stenosis;
boolean
C0242231 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
Coronary Stenosis additional lesion
Item
significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
boolean
C0221198 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0242231 (UMLS CUI [1,3])
Coronary Stenosis at Ostium
Item
have an ostial target lesion;
boolean
C0242231 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Thrombus
Item
angiographic evidence of thrombus within target lesion;
boolean
C0087086 (UMLS CUI [1])
Heavy Calcification
Item
heavily calcified lesion which cannot be successfully predilated;
boolean
C1533591 (UMLS CUI [1,1])
C0012356 (UMLS CUI [1,2])
LVEF
Item
documented left ventricular ejection fraction <=25%.
boolean
C0428772 (UMLS CUI [1])
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