ID

14091

Beskrivning

FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00233818

Länk

https://clinicaltrials.gov/show/NCT00233818

Nyckelord

  1. 2016-03-29 2016-03-29 -
Uppladdad den

29 mars 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Coronary Artery Disease NCT00233818

Eligibility Coronary Artery Disease NCT00233818

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs) or a positive ischemia study;
Beskrivning

Cardiac status

Datatyp

boolean

Alias
UMLS CUI [1]
C1277207
UMLS CUI [2]
C0151744
2. single de novo lesion requiring treatment in a major native coronary artery;
Beskrivning

Coronary stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0242231
3. target lesion is <=18mm in length (visual estimate);
Beskrivning

Size of lesion: length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1275593
UMLS CUI [1,2]
C1444754
4. target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
Beskrivning

Size of lesion: diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1275593
UMLS CUI [1,2]
C1301886
5. target lesion stenosis is >50% and <100% (visual estimate);
Beskrivning

Stenosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439165
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal;
Beskrivning

Myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428953
UMLS CUI [2]
C0523584
2. unprotected left main coronary disease with >=50% stenosis;
Beskrivning

Untreated coronary disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0332155
3. have an ostial target lesion;
Beskrivning

Ostial target lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0345120
4. angiographic evidence of thrombus within target lesion;
Beskrivning

Thrombus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0002971
5. calcified lesions which cannot be successfully predilated;
Beskrivning

Dilatation of calcified lesions

Datatyp

boolean

Alias
UMLS CUI [1]
C1533591
6. ejection fraction <=30%;
Beskrivning

Ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
7. target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
Beskrivning

Site of lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C0449695
8. totally occluded vessel;
Beskrivning

Occluded vessel

Datatyp

boolean

Alias
UMLS CUI [1]
C1386685

Similar models

Eligibility Coronary Artery Disease NCT00233818

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac status
Item
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs) or a positive ischemia study;
boolean
C1277207 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
Coronary stenosis
Item
2. single de novo lesion requiring treatment in a major native coronary artery;
boolean
C0242231 (UMLS CUI [1])
Size of lesion: length
Item
3. target lesion is <=18mm in length (visual estimate);
boolean
C1275593 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Size of lesion: diameter
Item
4. target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
boolean
C1275593 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Stenosis
Item
5. target lesion stenosis is >50% and <100% (visual estimate);
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Myocardial infarction
Item
1. a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal;
boolean
C0428953 (UMLS CUI [1])
C0523584 (UMLS CUI [2])
Untreated coronary disease
Item
2. unprotected left main coronary disease with >=50% stenosis;
boolean
C0010068 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Ostial target lesion
Item
3. have an ostial target lesion;
boolean
C0345120 (UMLS CUI [1])
Thrombus
Item
4. angiographic evidence of thrombus within target lesion;
boolean
C0087086 (UMLS CUI [1,1])
C0002971 (UMLS CUI [1,2])
Dilatation of calcified lesions
Item
5. calcified lesions which cannot be successfully predilated;
boolean
C1533591 (UMLS CUI [1])
Ejection fraction
Item
6. ejection fraction <=30%;
boolean
C0232174 (UMLS CUI [1])
Site of lesion
Item
7. target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
boolean
C0449695 (UMLS CUI [1])
Occluded vessel
Item
8. totally occluded vessel;
boolean
C1386685 (UMLS CUI [1])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial