ID

16884

Description

The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.; ODM derived from: https://clinicaltrials.gov/show/NCT00232791

Link

https://clinicaltrials.gov/show/NCT00232791

Keywords

Versions (1)
  1. 8/12/16 8/12/16 -
Uploaded on

August 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00232791

English

Eligibility Coronary Artery Disease NCT00232791

1 forms  
Inclusion Criteria
Description

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;
Description

Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1277207
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0340291
2. single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
Description

Lesion de novo Coronary artery | Therapeutic procedure Stent Single coronary vessel disease | Therapeutic procedure Stent Multiple vessel coronary artery disease | Multiple lesions Treated | Target Lesion Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205042
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0038257
UMLS CUI [2,3]
C0581374
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0038257
UMLS CUI [3,3]
C3805196
UMLS CUI [4,1]
C0577305
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C2986546
UMLS CUI [5,2]
C1522326
3. target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
Description

Target Lesion size Diameter | Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C1301886
UMLS CUI [2]
C0444684
4. target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
Description

Target Lesion Location Coronary artery Native | Lesion Length Maximum Stent

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1444754
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C0038257
5. target lesion stenosis is > 50% and < 100% (visual estimate).
Description

Target Lesion Stenosis | Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0678234
UMLS CUI [2]
C0444684
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

Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Creatine kinase (cardiac enzyme) level | Creatine kinase MB measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582803
UMLS CUI [2]
C0542269
UMLS CUI [3]
C3516327
UMLS CUI [4]
C0523584
2. unprotected left main coronary disease with more than 50% stenosis;
Description

Left main coronary artery disease | Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2]
C1261287
3. significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Description

Stenosis Significant Target Lesion Proximal | Stenosis Significant Target Lesion Distal | Revascularization Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0205107
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C2986546
UMLS CUI [2,4]
C0205108
UMLS CUI [3,1]
C0581603
UMLS CUI [3,2]
C0686904
4. have an ostial target lesion;
Description

Target Lesion Ostium

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0444567
5. angiographic evidence of thrombus within target lesion;
Description

Thrombus Within Target Lesion Evidence of | angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C2986546
UMLS CUI [1,4]
C0332120
UMLS CUI [2]
C0002978
6. calcified lesions which cannot be successfully predilated;
Description

Lesion Calcified

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
7. ejection fraction less than 30%;
Description

Cardiac ejection fraction

Data type

boolean

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

vessels; occlusion Total | TIMI grade 0

Data type

boolean

Alias
UMLS CUI [1,1]
C1386685
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C1299341
9. direct stenting;
Description

Stenting Direct

Data type

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C1947931
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Similar models

Eligibility Coronary Artery Disease NCT00232791

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia
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
C0002962 (UMLS CUI [1])
C1277207 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Lesion de novo Coronary artery | Therapeutic procedure Stent Single coronary vessel disease | Therapeutic procedure Stent Multiple vessel coronary artery disease | Multiple lesions Treated | Target Lesion Treated
Item
2. single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
C0581374 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0038257 (UMLS CUI [3,2])
C3805196 (UMLS CUI [3,3])
C0577305 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C2986546 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
Target Lesion size Diameter | Visual estimation
Item
3. target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
boolean
C2986546 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0444684 (UMLS CUI [2])
Target Lesion Location Coronary artery Native | Lesion Length Maximum Stent
Item
4. target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0038257 (UMLS CUI [2,4])
Target Lesion Stenosis | Visual estimation
Item
5. target lesion stenosis is > 50% and < 100% (visual estimate).
boolean
C2986546 (UMLS CUI [1,1])
C0678234 (UMLS CUI [1,2])
C0444684 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Creatine kinase (cardiac enzyme) level | Creatine kinase MB measurement
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
C0582803 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
C3516327 (UMLS CUI [3])
C0523584 (UMLS CUI [4])
Left main coronary artery disease | Stenosis
Item
2. unprotected left main coronary disease with more than 50% stenosis;
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2])
Stenosis Significant Target Lesion Proximal | Stenosis Significant Target Lesion Distal | Revascularization Patient need for
Item
3. significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
boolean
C1261287 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0205107 (UMLS CUI [1,4])
C1261287 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C2986546 (UMLS CUI [2,3])
C0205108 (UMLS CUI [2,4])
C0581603 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Target Lesion Ostium
Item
4. have an ostial target lesion;
boolean
C2986546 (UMLS CUI [1,1])
C0444567 (UMLS CUI [1,2])
Thrombus Within Target Lesion Evidence of | angiography
Item
5. angiographic evidence of thrombus within target lesion;
boolean
C0087086 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0002978 (UMLS CUI [2])
Lesion Calcified
Item
6. calcified lesions which cannot be successfully predilated;
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
Cardiac ejection fraction
Item
7. ejection fraction less than 30%;
boolean
C0232174 (UMLS CUI [1])
vessels; occlusion Total | TIMI grade 0
Item
8. totally occluded vessel (timi 0 level);
boolean
C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1299341 (UMLS CUI [2])
Stenting Direct
Item
9. direct stenting;
boolean
C2348535 (UMLS CUI [1,1])
C1947931 (UMLS CUI [1,2])
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