ID

35538

Description

Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy; ODM derived from: https://clinicaltrials.gov/show/NCT02072239

Lien

https://clinicaltrials.gov/show/NCT02072239

Mots-clés

Versions (1)
  1. 07/03/2019 07/03/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 mars 2019

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 NCT02072239

Anglais

Eligibility Coronary Artery Disease NCT02072239

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject will be eligible for inclusion in the investigation if he/she:
Description

Study Subject Eligible

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
is between the ages of 18 and 80 years of age, inclusive
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
requires coronary atery bypass graft (cabg) surgery with minimum of one svg used to bypass a stenosis in the right coronary, the circumflex, a diagonal, or an obtuse marginal artery, due to atherosclerotic coronary artery disease
Description

Requirement Coronary Artery Bypass Surgery | Saphenous vein graft Quantity | Stenosis Right coronary artery | Stenosis Circumflex artery | Stenosis Diagonal artery | Stenosis Obtuse marginal artery | Etiology Coronary Arteriosclerosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0010055
UMLS CUI [2,1]
C0729538
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C0226042
UMLS CUI [4,1]
C1261287
UMLS CUI [4,2]
C1305727
UMLS CUI [5,1]
C1261287
UMLS CUI [5,2]
C1282006
UMLS CUI [6,1]
C1261287
UMLS CUI [6,2]
C0226040
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C0010054
is able to give their informed written consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
is willing and able to complete all follow-up visits and procedures
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject will be excluded from participation in the investigation if he/she:
Description

Study Subject Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332196
is currently enrolled in another clinical investigation
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
Description

Compliance behavior Postoperative Unable | Anticoagulation Therapy Unable | Contrast media allergy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C1299582
UMLS CUI [3]
C0570562
is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis
Description

Thrombophilia | Venous Thrombosis idiopathic | Arterial thrombosis idiopathic

Type de données

boolean

Alias
UMLS CUI [1]
C0398623
UMLS CUI [2,1]
C0042487
UMLS CUI [2,2]
C0332240
UMLS CUI [3,1]
C0151942
UMLS CUI [3,2]
C0332240
has had an acute mi within the last 21 days
Description

Acute myocardial infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0155626
has had a previous cabg
Description

Coronary Artery Bypass Surgery Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0205156
requires emergency surgery
Description

Requirement Emergency surgical procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C2216322
has a left ejection fraction (lef) less than 20%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
has a target vessel stenosis of less than 70%
Description

Target vessel Stenosis Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1261287
UMLS CUI [1,3]
C0439165
has a transmural infarct of the target artery territory
Description

Transmural infarct Target Artery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0333561
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0003842
currently requiring dialysis
Description

Requirement Dialysis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0011946
is having concomitant-surgery of any kind
Description

Operative Surgical Procedures Kind Any

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
has varicose veins
Description

Varicosity

Type de données

boolean

Alias
UMLS CUI [1]
C0042345
has had previous saphenectomy
Description

Saphenectomy Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C1168178
UMLS CUI [1,2]
C0205156
Retour au début de la page

Similar models

Eligibility Coronary Artery Disease NCT02072239

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Eligible
Item
subject will be eligible for inclusion in the investigation if he/she:
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
Age
Item
is between the ages of 18 and 80 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Requirement Coronary Artery Bypass Surgery | Saphenous vein graft Quantity | Stenosis Right coronary artery | Stenosis Circumflex artery | Stenosis Diagonal artery | Stenosis Obtuse marginal artery | Etiology Coronary Arteriosclerosis
Item
requires coronary atery bypass graft (cabg) surgery with minimum of one svg used to bypass a stenosis in the right coronary, the circumflex, a diagonal, or an obtuse marginal artery, due to atherosclerotic coronary artery disease
boolean
C1514873 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0729538 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1261287 (UMLS CUI [3,1])
C0226042 (UMLS CUI [3,2])
C1261287 (UMLS CUI [4,1])
C1305727 (UMLS CUI [4,2])
C1261287 (UMLS CUI [5,1])
C1282006 (UMLS CUI [5,2])
C1261287 (UMLS CUI [6,1])
C0226040 (UMLS CUI [6,2])
C0015127 (UMLS CUI [7,1])
C0010054 (UMLS CUI [7,2])
Informed Consent
Item
is able to give their informed written consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
is willing and able to complete all follow-up visits and procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Excluded
Item
subject will be excluded from participation in the investigation if he/she:
boolean
C0681850 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Study Subject Participation Status
Item
is currently enrolled in another clinical investigation
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Postoperative Unable | Anticoagulation Therapy Unable | Contrast media allergy
Item
is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
boolean
C1321605 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0570562 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Thrombophilia | Venous Thrombosis idiopathic | Arterial thrombosis idiopathic
Item
shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis
boolean
C0398623 (UMLS CUI [1])
C0042487 (UMLS CUI [2,1])
C0332240 (UMLS CUI [2,2])
C0151942 (UMLS CUI [3,1])
C0332240 (UMLS CUI [3,2])
Acute myocardial infarction
Item
has had an acute mi within the last 21 days
boolean
C0155626 (UMLS CUI [1])
Coronary Artery Bypass Surgery Previous
Item
has had a previous cabg
boolean
C0010055 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Requirement Emergency surgical procedure
Item
requires emergency surgery
boolean
C1514873 (UMLS CUI [1,1])
C2216322 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
has a left ejection fraction (lef) less than 20%
boolean
C0428772 (UMLS CUI [1])
Target vessel Stenosis Percentage
Item
has a target vessel stenosis of less than 70%
boolean
C0449618 (UMLS CUI [1,1])
C1261287 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Transmural infarct Target Artery
Item
has a transmural infarct of the target artery territory
boolean
C0333561 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0003842 (UMLS CUI [1,3])
Requirement Dialysis
Item
currently requiring dialysis
boolean
C1514873 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Operative Surgical Procedures Kind Any
Item
is having concomitant-surgery of any kind
boolean
C0543467 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Varicosity
Item
has varicose veins
boolean
C0042345 (UMLS CUI [1])
Saphenectomy Previous
Item
has had previous saphenectomy
boolean
C1168178 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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