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

  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

Eligibility Coronary Artery Disease NCT00233818

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

Similar models

Eligibility Coronary Artery Disease NCT00233818

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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