ID

10834

Description

The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. (E-SIRIUS) ODM derived from http://clinicaltrials.gov/show/NCT00235144

Link

http://clinicaltrials.gov/show/NCT00235144

Keywords

Versions (2)
  1. 2/15/12 2/15/12 -
  2. 6/8/15 6/8/15 - Martin Dugas
Uploaded on

June 8, 2015

DOI

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License

Creative Commons BY 4.0
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Coronary Artery Disease Eligibility BX VELOCITY Stent NCT00235144

German English

Eligibility BX VELOCITY Stent Coronary Artery Disease NCT00235144

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

18 years and older
Description

18 years and older

Data type

boolean

Alias
UMLS CUI-1
C0001779
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

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

Data type

boolean

Alias
UMLS CUI-1
C0002962
UMLS CUI-2
C1277207
Treatment of a single de novo native coronary artery 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

single de novo native coronary artery lesion

Data type

boolean

Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate)
Description

target vessel diameter

Data type

boolean

Target lesion is >=15mm and <=32mm in length (visual estimate)
Description

length of target lesion

Data type

boolean

Target lesion stenosis is >50% and <100% (visual estimate)
Description

target lesion stenosis

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

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

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

Data type

boolean

Alias
UMLS CUI-1
C0027051
Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction
Description

unstable Angina pectoris

Data type

boolean

Alias
UMLS CUI-1
C0002965
Unprotected left main coronary disease with >=50% stenosis
Description

Unprotected left main coronary disease with >=50% stenosis

Data type

boolean

Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff
Description

significant stenoses proximal or distal to the target lesion

Data type

boolean

Have an ostial target lesion
Description

ostial target lesion

Data type

boolean

Angiographic evidence of thrombus within target lesion
Description

thrombus within target lesion

Data type

boolean

Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
Description

heavily calcified lesion

Data type

boolean

Documented left ventricular ejection fraction <=25%
Description

Documented left ventricular ejection fraction <=25%

Data type

boolean

Alias
UMLS CUI-1
C0232174
Medical concepts
Description

Medical concepts

Single vessel disease
Description

Single vessel disease

Data type

string

Alias
UMLS CUI 2011AA
C0856737
MedDRA 14.1
10040731
Double vessel disease
Description

Double vessel disease

Data type

string

Alias
UMLS CUI 2011AA
C0919945
MedDRA 14.1
10049943
Triple vessel disease
Description

Triple vessel disease

Data type

string

Alias
UMLS CUI 2011AA
C0856738
MedDRA 14.1
10044676
Coronary artery disease (CAD)
Description

Coronary Heart Disease (CHD)

Data type

string

Alias
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
Vessel lumen diameter
Description

Vessel lumen diameter

Data type

string

Alias
UMLS CUI 2011AA
C1301408
SNOMED CT 2011_0131
397413000
Stenotic lesion length
Description

Stenotic lesion length

Data type

string

Alias
UMLS CUI 2011AA
C1443266
SNOMED CT 2011_0131
408716009
Stenosis
Description

Stenosis

Data type

string

Alias
UMLS CUI 2011AA
C1261287
Acute myocardial infarction
Description

Acute myocardial infarction

Data type

string

Alias
UMLS CUI 2011AA
C0155626
SNOMED CT 2011_0131
57054005
MedDRA 14.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
CK
Description

Creatine Kinase Measurement

Data type

string

Alias
UMLS CUI 2011AA
C0201973
SNOMED CT 2011_0131
397798009
MedDRA 14.1
10009218
CK-MB
Description

Creatine Kinase MB Measurement

Data type

string

Alias
UMLS CUI 2011AA
C0523584
SNOMED CT 2011_0131
104613001
MedDRA 14.1
10009220
OPERATIONS / PROCEDURES
Description

OPERATIONS / PROCEDURES

Data type

string

Alias
UMLS CUI 2011AA
C0087111
Coronary arteriography
Description

Coronary angiography

Data type

string

Alias
UMLS CUI 2011AA
C0085532
SNOMED CT 2011_0131
33367005
MedDRA 14.1
10003200
Thrombus
Description

Thrombus

Data type

string

Alias
UMLS CUI 2011AA
C0087086
SNOMED CT 2011_0131
396339007
Calcification
Description

Calcification

Data type

string

Alias
UMLS CUI 2011AA
C1533591
MedDRA 14.1
10012367
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Similar models

Eligibility BX VELOCITY Stent Coronary Artery Disease NCT00235144

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI-1)
Angina Pectoris
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)
C1277207 (UMLS CUI-2)
single de novo native coronary artery lesion
Item
Treatment of a single de novo native coronary artery 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
target vessel diameter
Item
Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate)
boolean
length of target lesion
Item
Target lesion is >=15mm and <=32mm in length (visual estimate)
boolean
target lesion stenosis
Item
Target lesion stenosis is >50% and <100% (visual estimate)
boolean
Item Group
Exclusion criteria
myocardial infarction
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)
unstable AP
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)
Unprotected left main coronary disease with >=50% stenosis
Item
Unprotected left main coronary disease with >=50% stenosis
boolean
significant stenoses proximal or distal to the target lesion
Item
Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff
boolean
ostial target lesion
Item
Have an ostial target lesion
boolean
thrombus within target lesion
Item
Angiographic evidence of thrombus within target lesion
boolean
heavily calcified lesion
Item
Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
boolean
EF <= 25%
Item
Documented left ventricular ejection fraction <=25%
boolean
C0232174 (UMLS CUI-1)
Item Group
Medical concepts
Single vessel disease
Item
Single vessel disease
string
C0856737 (UMLS CUI 2011AA)
10040731 (MedDRA 14.1)
Double vessel disease
Item
Double vessel disease
string
C0919945 (UMLS CUI 2011AA)
10049943 (MedDRA 14.1)
Triple vessel disease
Item
Triple vessel disease
string
C0856738 (UMLS CUI 2011AA)
10044676 (MedDRA 14.1)
Coronary Heart Disease (CHD)
Item
Coronary artery disease (CAD)
string
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
Vessel lumen diameter
Item
Vessel lumen diameter
string
C1301408 (UMLS CUI 2011AA)
397413000 (SNOMED CT 2011_0131)
Stenotic lesion length
Item
Stenotic lesion length
string
C1443266 (UMLS CUI 2011AA)
408716009 (SNOMED CT 2011_0131)
Stenosis
Item
Stenosis
string
C1261287 (UMLS CUI 2011AA)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI 2011AA)
57054005 (SNOMED CT 2011_0131)
10000891 (MedDRA 14.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
Creatine Kinase Measurement
Item
CK
string
C0201973 (UMLS CUI 2011AA)
397798009 (SNOMED CT 2011_0131)
10009218 (MedDRA 14.1)
Creatine Kinase MB Measurement
Item
CK-MB
string
C0523584 (UMLS CUI 2011AA)
104613001 (SNOMED CT 2011_0131)
10009220 (MedDRA 14.1)
OPERATIONS / PROCEDURES
Item
OPERATIONS / PROCEDURES
string
C0087111 (UMLS CUI 2011AA)
Coronary angiography
Item
Coronary arteriography
string
C0085532 (UMLS CUI 2011AA)
33367005 (SNOMED CT 2011_0131)
10003200 (MedDRA 14.1)
Thrombus
Item
Thrombus
string
C0087086 (UMLS CUI 2011AA)
396339007 (SNOMED CT 2011_0131)
Calcification
Item
Calcification
string
C1533591 (UMLS CUI 2011AA)
10012367 (MedDRA 14.1)
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