ID

14084

Beschrijving

The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.; ODM derived from: https://clinicaltrials.gov/show/NCT00233805

Link

https://clinicaltrials.gov/show/NCT00233805

Trefwoorden

  1. 29-03-16 29-03-16 -
Geüploaded op

29 maart 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00233805

Eligibility Coronary Artery Disease NCT00233805

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 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-iii) or patients with documented silent ischemia;
Beschrijving

Cardiac status

Datatype

boolean

Alias
UMLS CUI [1]
C1277207
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340291
2. single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
Beschrijving

Stenting

Datatype

boolean

Alias
UMLS CUI [1]
C0687568
3. target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate);
Beschrijving

Size of lesion

Datatype

boolean

Alias
UMLS CUI [1]
C1275593
4. target lesion is located in a native coronary artery which can be covered by one stent (single lesion);
Beschrijving

Stenting in native coronary artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C2957458
UMLS CUI [1,2]
C0687568
5. target lesion stenosis is >50% and <100% (timi i) (visual estimate).
Beschrijving

Size of stenosis

Datatype

boolean

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

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;
Beschrijving

Finding: Myocardial infarction

Datatype

boolean

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

Untreated main coronary disease

Datatype

boolean

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

Ostial target lesion

Datatype

boolean

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

Angiographic evidence of thrombus

Datatype

boolean

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

Dilatation of calcified lesions

Datatype

boolean

Alias
UMLS CUI [1,1]
C1533591
UMLS CUI [1,2]
C0012356
6. ejection fraction <=30%;
Beschrijving

Ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0232174
7. totally occluded vessel (timi 0 level);
Beschrijving

Timi 0 level

Datatype

boolean

Alias
UMLS CUI [1]
C3272284
8. target lesion involves bifurcation including a side branch >=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
Beschrijving

Site of lesion

Datatype

boolean

Alias
UMLS CUI [1]
C0449695
9. planned direct stenting.
Beschrijving

Planned stenting

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0687568

Similar models

Eligibility Coronary Artery Disease NCT00233805

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac status
Item
1. 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-iii) or patients with documented silent ischemia;
boolean
C1277207 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0340291 (UMLS CUI [3])
Stenting
Item
2. single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
boolean
C0687568 (UMLS CUI [1])
Size of lesion
Item
3. target lesion is >= 2.5 and <= 3.5mm in diameter (visual estimate);
boolean
C1275593 (UMLS CUI [1])
Stenting in native coronary artery
Item
4. target lesion is located in a native coronary artery which can be covered by one stent (single lesion);
boolean
C2957458 (UMLS CUI [1,1])
C0687568 (UMLS CUI [1,2])
Size of stenosis
Item
5. target lesion stenosis is >50% and <100% (timi i) (visual estimate).
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Finding: 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 main 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])
Angiographic evidence of 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 [1,1])
C0012356 (UMLS CUI [1,2])
Ejection fraction
Item
6. ejection fraction <=30%;
boolean
C0232174 (UMLS CUI [1])
Timi 0 level
Item
7. totally occluded vessel (timi 0 level);
boolean
C3272284 (UMLS CUI [1])
Site of lesion
Item
8. target lesion involves bifurcation including a side branch >=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
boolean
C0449695 (UMLS CUI [1])
Planned stenting
Item
9. planned direct stenting.
boolean
C1301732 (UMLS CUI [1,1])
C0687568 (UMLS CUI [1,2])

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