ID

16887

Description

Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION); ODM derived from: https://clinicaltrials.gov/show/NCT00233779

Link

https://clinicaltrials.gov/show/NCT00233779

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 NCT00233779

English

Eligibility Coronary Artery Disease NCT00233779

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient must be minimum 18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. 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
3 treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
Description

Therapeutic procedure Lesion Coronary artery Native | Lesion Diameter Stenosis Visual estimation | Stent dissection of coronary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0678234
UMLS CUI [2,4]
C0444684
UMLS CUI [3,1]
C0038257
UMLS CUI [3,2]
C0340648
4. the target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);
Description

Target Lesion Diameter Visual estimation

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0444684
5. the target lesion can be covered with a single 18mm stent;
Description

Target Lesion Covered Stent

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1999244
UMLS CUI [1,3]
C0038257
6. target lesion stenosis is >50% and <100% (timi i) (visual estimate);
Description

Target Lesion Stenosis Visual estimation | TIMI grade 1: penetration without perfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0678234
UMLS CUI [1,3]
C0444684
UMLS CUI [2]
C1299340
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
Description

Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Measurement of total creatine kinase (CK) | Creatine kinase (cardiac enzyme) level | CK-MB in whole blood

Data type

boolean

Alias
UMLS CUI [1]
C0582803
UMLS CUI [2]
C0542269
UMLS CUI [3]
C3525717
UMLS CUI [4]
C3516327
UMLS CUI [5]
C4029718
2. target lesion is due to in-stent restenosis;
Description

Target Lesion Due to In-stent coronary artery restenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1868718
3. ejection fraction 30%;
Description

Cardiac ejection fraction

Data type

boolean

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

vessels; occlusion Total | TIMI grade 0: no perfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1386685
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C1299341
5. impaired renal function (creatinine > 3.0 mg/dl);
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
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Similar models

Eligibility Coronary Artery Disease NCT00233779

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. the patient must be minimum 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Angina Pectoris | Canadian Cardiovascular Society classification of angina | Angina, Unstable | Silent myocardial ischemia
Item
2. 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])
Therapeutic procedure Lesion Coronary artery Native | Lesion Diameter Stenosis Visual estimation | Stent dissection of coronary artery
Item
3 treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
boolean
C0087111 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0678234 (UMLS CUI [2,3])
C0444684 (UMLS CUI [2,4])
C0038257 (UMLS CUI [3,1])
C0340648 (UMLS CUI [3,2])
Target Lesion Diameter Visual estimation
Item
4. the target lesion is >/=2.0 mm and </=2.5mm in diameter (visual estimate);
boolean
C2986546 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
Target Lesion Covered Stent
Item
5. the target lesion can be covered with a single 18mm stent;
boolean
C2986546 (UMLS CUI [1,1])
C1999244 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
Target Lesion Stenosis Visual estimation | TIMI grade 1: penetration without perfusion
Item
6. target lesion stenosis is >50% and <100% (timi i) (visual estimate);
boolean
C2986546 (UMLS CUI [1,1])
C0678234 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
C1299340 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Measurement of total creatine kinase (CK) | Creatine kinase (cardiac enzyme) level | CK-MB in whole blood
Item
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remain above normal at the time of treatment;
boolean
C0582803 (UMLS CUI [1])
C0542269 (UMLS CUI [2])
C3525717 (UMLS CUI [3])
C3516327 (UMLS CUI [4])
C4029718 (UMLS CUI [5])
Target Lesion Due to In-stent coronary artery restenosis
Item
2. target lesion is due to in-stent restenosis;
boolean
C2986546 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1868718 (UMLS CUI [1,3])
Cardiac ejection fraction
Item
3. ejection fraction 30%;
boolean
C0232174 (UMLS CUI [1])
vessels; occlusion Total | TIMI grade 0: no perfusion
Item
4. totally occluded vessel (timi 0 level);
boolean
C1386685 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C1299341 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum
Item
5. impaired renal function (creatinine > 3.0 mg/dl);
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
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