ID

15035

Description

A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.; ODM derived from: https://clinicaltrials.gov/show/NCT00234455

Lien

https://clinicaltrials.gov/show/NCT00234455

Mots-clés

  1. 11/05/2016 11/05/2016 -
  2. 12/05/2016 12/05/2016 -
Téléchargé le

12 mai 2016

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00234455

Eligibility Coronary Artery Disease NCT00234455

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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) or patients with documented silent ischemia;
Description

Angina pectoris or unstable angina pectoris or silent myocardial ischemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0002965
UMLS CUI [1,3]
C0340291
2. involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
Description

Coronary Artery Stenosis Lesions: localisation, Number,

Type de données

boolean

Alias
UMLS CUI [1]
C0449791
UMLS CUI [2,1]
C0475264
UMLS CUI [2,2]
C0242231
3. has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
Description

Coronary artery stenosis localisation and severity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0475264
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0439793
4. has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line qca proximal to the bifurcation;
Description

coronary artery diameter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0456389
5. has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line qca.
Description

coronary artery diameter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0456389
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented elevation of ck levels > 2 times normal or ck-mb levels > 3 times normal within the preceding 24 hours and/or the ck and ck-mb enzymes remain above normal at the time of treatment;
Description

myocardial infarction severity by ecg and ck (ckmb)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0439793
UMLS CUI [1,3]
C1623258
UMLS CUI [1,4]
C0201973
2. has unstable angina classified as braunwald a i-iii, or iii b or c, or is having a peri infarction;
Description

Unstable angina or Peri Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
3. has a bifurcation lesion in a non protected left main;
Description

Bifurcation lesion localisation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C0475264
4. has an ejection fraction <=35%;
Description

LVEF

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
5. there is presence of thrombus in the bifurcation lesion;
Description

Thrombus

Type de données

boolean

Alias
UMLS CUI [1]
C0087086
6. has a totally occluded vessel.
Description

Cardiovascular Occlusion

Type de données

boolean

Alias
UMLS CUI [1]
C1110554

Similar models

Eligibility Coronary Artery Disease NCT00234455

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Angina pectoris or unstable angina pectoris or silent myocardial ischemia
Item
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) or patients with documented silent ischemia;
boolean
C0002962 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0340291 (UMLS CUI [1,3])
Coronary Artery Stenosis Lesions: localisation, Number,
Item
2. involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
boolean
C0449791 (UMLS CUI [1])
C0475264 (UMLS CUI [2,1])
C0242231 (UMLS CUI [2,2])
Coronary artery stenosis localisation and severity
Item
3. has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
boolean
C0242231 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0242231 (UMLS CUI [2,1])
C0439793 (UMLS CUI [2,2])
coronary artery diameter
Item
4. has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line qca proximal to the bifurcation;
boolean
C0205042 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
coronary artery diameter
Item
5. has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line qca.
boolean
C0205042 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
myocardial infarction severity by ecg and ck (ckmb)
Item
1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented elevation of ck levels > 2 times normal or ck-mb levels > 3 times normal within the preceding 24 hours and/or the ck and ck-mb enzymes remain above normal at the time of treatment;
boolean
C0027051 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0201973 (UMLS CUI [1,4])
Unstable angina or Peri Infarction
Item
2. has unstable angina classified as braunwald a i-iii, or iii b or c, or is having a peri infarction;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Bifurcation lesion localisation
Item
3. has a bifurcation lesion in a non protected left main;
boolean
C1299363 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
LVEF
Item
4. has an ejection fraction <=35%;
boolean
C0428772 (UMLS CUI [1])
Thrombus
Item
5. there is presence of thrombus in the bifurcation lesion;
boolean
C0087086 (UMLS CUI [1])
Cardiovascular Occlusion
Item
6. has a totally occluded vessel.
boolean
C1110554 (UMLS CUI [1])

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