ID

28468

Description

Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions; ODM derived from: https://clinicaltrials.gov/show/NCT00595647

Link

https://clinicaltrials.gov/show/NCT00595647

Keywords

Versions (1)
  1. 1/16/18 1/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00595647

English

Eligibility Coronary Artery Disease NCT00595647

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing svg pci with a target vessel reference diameter ≤ 5.5 mm (visual estimate)
Description

Saphenous vein graft | Percutaneous Coronary Intervention | Target vessel Diameter Size

Data type

boolean

Alias
UMLS CUI [1]
C0729538
UMLS CUI [2]
C1532338
UMLS CUI [3,1]
C0449618
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0456389
documented silent ischemia, stable angina pectoris canadian cardiovascular society (ccs) class i to iv, or acute coronary syndrome
Description

Silent myocardial ischemia | Stable angina CCS Grading Scale Class | Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0340291
UMLS CUI [2,1]
C0340288
UMLS CUI [2,2]
C1879987
UMLS CUI [3]
C0948089
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous stent implantation anywhere in the target svg
Description

Placement of stent Target Saphenous vein graft

Data type

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0729538
concomitant native vessel pci
Description

Percutaneous Coronary Intervention Vessel Native

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0302891
svg age <6 months
Description

Saphenous vein graft Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C0332185
arterial grafts
Description

Arterial graft

Data type

boolean

Alias
UMLS CUI [1]
C0450140
oral anticoagulation
Description

Anticoagulation Therapy Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
platelet count <100x109/l or >700x109/l, white blood cell count <3000 cells/mm3
Description

Platelet Count measurement | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
any major non-cardiac condition with a life expectancy <12 months
Description

Medical condition Major | Exception Heart Diseases | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
planned elective surgery in the next 12 months
Description

Elective Surgical Procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
known allergies against the components tested
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
enrolled in other study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
no consent
Description

Informed Consent Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
patients unlikely to comply to the study treatment and the follow-up visits
Description

Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
age <18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
known pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Coronary Artery Disease NCT00595647

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Saphenous vein graft | Percutaneous Coronary Intervention | Target vessel Diameter Size
Item
patients undergoing svg pci with a target vessel reference diameter ≤ 5.5 mm (visual estimate)
boolean
C0729538 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0449618 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0456389 (UMLS CUI [3,3])
Silent myocardial ischemia | Stable angina CCS Grading Scale Class | Acute Coronary Syndrome
Item
documented silent ischemia, stable angina pectoris canadian cardiovascular society (ccs) class i to iv, or acute coronary syndrome
boolean
C0340291 (UMLS CUI [1])
C0340288 (UMLS CUI [2,1])
C1879987 (UMLS CUI [2,2])
C0948089 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Placement of stent Target Saphenous vein graft
Item
previous stent implantation anywhere in the target svg
boolean
C0522776 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0729538 (UMLS CUI [1,3])
Percutaneous Coronary Intervention Vessel Native
Item
concomitant native vessel pci
boolean
C1532338 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0302891 (UMLS CUI [1,3])
Saphenous vein graft Recent
Item
svg age <6 months
boolean
C0729538 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Arterial graft
Item
arterial grafts
boolean
C0450140 (UMLS CUI [1])
Anticoagulation Therapy Oral
Item
oral anticoagulation
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Platelet Count measurement | White Blood Cell Count procedure
Item
platelet count <100x109/l or >700x109/l, white blood cell count <3000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Medical condition Major | Exception Heart Diseases | Life Expectancy
Item
any major non-cardiac condition with a life expectancy <12 months
boolean
C3843040 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Elective Surgical Procedures Planned
Item
planned elective surgery in the next 12 months
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
known allergies against the components tested
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status
Item
enrolled in other study
boolean
C2348568 (UMLS CUI [1])
Informed Consent Lacking
Item
no consent
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Protocol Compliance Unlikely
Item
patients unlikely to comply to the study treatment and the follow-up visits
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
known pregnancy
boolean
C0032961 (UMLS CUI [1])
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