ID

14091

Description

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

Link

https://clinicaltrials.gov/show/NCT00233818

Keywords

Versions (1)
  1. 3/29/16 3/29/16 -
Uploaded on

March 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00233818

English

Eligibility Coronary Artery Disease NCT00233818

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Cardiac status

Data type

boolean

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

Coronary stenosis

Data type

boolean

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

Size of lesion: length

Data type

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);
Description

Size of lesion: diameter

Data type

boolean

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

Stenosis

Data type

boolean

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

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;
Description

Myocardial infarction

Data type

boolean

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

Untreated coronary disease

Data type

boolean

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

Ostial target lesion

Data type

boolean

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

Thrombus

Data type

boolean

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

Dilatation of calcified lesions

Data type

boolean

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

Ejection fraction

Data type

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);
Description

Site of lesion

Data type

boolean

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

Occluded vessel

Data type

boolean

Alias
UMLS CUI [1]
C1386685
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Similar models

Eligibility Coronary Artery Disease NCT00233818

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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