ID

10834

Beschrijving

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

Trefwoorden

  1. 15-02-12 15-02-12 -
  2. 08-06-15 08-06-15 - Martin Dugas
Geüploaded op

8 juni 2015

DOI

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Licentie

Creative Commons BY 4.0

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Coronary Artery Disease Eligibility BX VELOCITY Stent NCT00235144

Eligibility BX VELOCITY Stent Coronary Artery Disease NCT00235144

Einschlusskriterien
Beschrijving

Einschlusskriterien

18 Jahre und älter
Beschrijving

Age

Datatype

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
Beschrijving

Angina Pectoris

Datatype

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
Beschrijving

single de novo native coronary artery lesion

Datatype

boolean

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

target vessel diameter

Datatype

boolean

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

length of target lesion

Datatype

boolean

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

target lesion stenosis

Datatype

boolean

Ausschlusskriterien
Beschrijving

Ausschlusskriterien

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
Beschrijving

myocardial infarction

Datatype

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
Beschrijving

unstable AP

Datatype

boolean

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

Unprotected left main coronary disease with >=50% stenosis

Datatype

boolean

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

significant stenoses proximal or distal to the target lesion

Datatype

boolean

Have an ostial target lesion
Beschrijving

ostial target lesion

Datatype

boolean

Angiographic evidence of thrombus within target lesion
Beschrijving

thrombus within target lesion

Datatype

boolean

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

heavily calcified lesion

Datatype

boolean

Documented left ventricular ejection fraction <=25%
Beschrijving

EF <= 25%

Datatype

boolean

Alias
UMLS CUI-1
C0232174
Medizinische Konzepte
Beschrijving

Medizinische Konzepte

Ein-Gefäß-Erkrankung
Beschrijving

Single vessel disease

Datatype

string

Alias
UMLS CUI 2011AA
C0856737
MedDRA 14.1
10040731
Zwei-Gefäß-Erkrankung
Beschrijving

Double vessel disease

Datatype

string

Alias
UMLS CUI 2011AA
C0919945
MedDRA 14.1
10049943
Drei-Gefäß-Erkrankung
Beschrijving

Triple vessel disease

Datatype

string

Alias
UMLS CUI 2011AA
C0856738
MedDRA 14.1
10044676
Koronare Herzerkrankung
Beschrijving

Coronary Heart Disease (CHD)

Datatype

string

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

Vessel lumen diameter

Datatype

string

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

Stenotic lesion length

Datatype

string

Alias
UMLS CUI 2011AA
C1443266
SNOMED CT 2011_0131
408716009
Stenose
Beschrijving

Stenosis

Datatype

string

Alias
UMLS CUI 2011AA
C1261287
Akuter Myokardinfarkt
Beschrijving

Acute myocardial infarction

Datatype

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
Beschrijving

Creatine Kinase Measurement

Datatype

string

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

Creatine Kinase MB Measurement

Datatype

string

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

OPERATIONS / PROCEDURES

Datatype

string

Alias
UMLS CUI 2011AA
C0087111
Koronarangiographie
Beschrijving

Coronary angiography

Datatype

string

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

Thrombus

Datatype

string

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

Calcification

Datatype

string

Alias
UMLS CUI 2011AA
C1533591
MedDRA 14.1
10012367

Similar models

Eligibility BX VELOCITY Stent Coronary Artery Disease NCT00235144

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Einschlusskriterien
Age
Item
18 Jahre und älter
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
Ausschlusskriterien
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
Medizinische Konzepte
Single vessel disease
Item
Ein-Gefäß-Erkrankung
string
C0856737 (UMLS CUI 2011AA)
10040731 (MedDRA 14.1)
Double vessel disease
Item
Zwei-Gefäß-Erkrankung
string
C0919945 (UMLS CUI 2011AA)
10049943 (MedDRA 14.1)
Triple vessel disease
Item
Drei-Gefäß-Erkrankung
string
C0856738 (UMLS CUI 2011AA)
10044676 (MedDRA 14.1)
Coronary Heart Disease (CHD)
Item
Koronare Herzerkrankung
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
Stenose
string
C1261287 (UMLS CUI 2011AA)
Acute myocardial infarction
Item
Akuter Myokardinfarkt
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
Koronarangiographie
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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