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

Lien

https://clinicaltrials.gov/show/NCT00233779

Mots-clés

Versions (1)
  1. 12/08/2016 12/08/2016 -
Téléchargé le

12 août 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Coronary Artery Disease NCT00233779

Anglais

Eligibility Coronary Artery Disease NCT00233779

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

vessels; occlusion Total | TIMI grade 0: no perfusion

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
Retour au début de la page

Similar models

Eligibility Coronary Artery Disease NCT00233779

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial