ID

35538

Description

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

Link

https://clinicaltrials.gov/show/NCT02072239

Keywords

Versions (1)
  1. 3/7/19 3/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02072239

English

Eligibility Coronary Artery Disease NCT02072239

1 forms  
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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Protocol Compliance

Data type

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

Data type

boolean

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

Study Subject Participation Status

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Coronary Artery Bypass Surgery Previous

Data type

boolean

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

Requirement Emergency surgical procedure

Data type

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

Data type

boolean

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

Target vessel Stenosis Percentage

Data type

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

Data type

boolean

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

Requirement Dialysis

Data type

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

Data type

boolean

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

Varicosity

Data type

boolean

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

Saphenectomy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1168178
UMLS CUI [1,2]
C0205156
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Similar models

Eligibility Coronary Artery Disease NCT02072239

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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