ID

41432

Description

FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00233792

Link

https://clinicaltrials.gov/show/NCT00233792

Keywords

  1. 1/6/16 1/6/16 -
  2. 10/6/20 10/6/20 -
Copyright Holder

Cordis Corporation

Uploaded on

October 6, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00233792

Eligibility Coronary Artery Disease NCT00233792

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0002962
2. single de novo or restenotic lesion requiring treatment in a major native coronary artery;
Description

2. single de novo or restenotic lesion requiring treatment in a major native coronary artery;

Data type

boolean

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

Length

Data type

boolean

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

diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C0221198
5. target lesion stenosis is >50% and <100% (visual estimate);
Description

stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0242231
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]
C0027051
UMLS CUI [2]
C0523584
UMLS CUI [3]
C0201973
2. unprotected left main coronary disease with >=50% stenosis;
Description

left main coronary disease

Data type

boolean

Alias
UMLS CUI [1]
C0010068
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 within target lesion

Data type

boolean

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

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

bifurcation

Data type

boolean

Alias
UMLS CUI [1]
C3640041
8. totally occluded vessel;
Description

totally occluded vessel

Data type

boolean

Alias
UMLS CUI [1]
C1110554

Similar models

Eligibility Coronary Artery Disease NCT00233792

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs) or a positive ischemia study;
Item
1. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs) or a positive ischemia study;
boolean
C0002962 (UMLS CUI [1])
2. single de novo or restenotic lesion requiring treatment in a major native coronary artery;
Item
2. single de novo or restenotic lesion requiring treatment in a major native coronary artery;
boolean
C0242231 (UMLS CUI [1])
Length
Item
3. target lesion is <=18mm in length (visual estimate);
boolean
C1444754 (UMLS CUI [1])
diameter
Item
4. target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
boolean
C1301886 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
stenosis
Item
5. target lesion stenosis is >50% and <100% (visual estimate);
boolean
C0242231 (UMLS CUI [1])
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
C0027051 (UMLS CUI [1])
C0523584 (UMLS CUI [2])
C0201973 (UMLS CUI [3])
left main coronary disease
Item
2. unprotected left main coronary disease with >=50% stenosis;
boolean
C0010068 (UMLS CUI [1])
ostial target lesion
Item
3. have an ostial target lesion;
boolean
C0345120 (UMLS CUI [1])
thrombus within target lesion
Item
4. angiographic evidence of thrombus within target lesion;
boolean
C0087086 (UMLS CUI [1])
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])
bifurcation
Item
7. target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
boolean
C3640041 (UMLS CUI [1])
totally occluded vessel
Item
8. totally occluded vessel;
boolean
C1110554 (UMLS CUI [1])

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