ID

20490

Description

SCRIPPS V: Intracoronary Brachytherapy for Recurrent Restenosis After Multiple Drug-Eluting Stents; ODM derived from: https://clinicaltrials.gov/show/NCT00714545

Link

https://clinicaltrials.gov/show/NCT00714545

Keywords

  1. 2/25/17 2/25/17 -
Uploaded on

February 25, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT00714545

Eligibility Coronary Artery Disease NCT00714545

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. eligible for percutaneous coronary intervention.
Description

Percutaneous coronary intervention

Data type

boolean

Alias
UMLS CUI [1]
C1532338
3. target lesion with recurrent restenosis (>50% by visual estimate) previously treated with any 2 or more combination of des stents.
Description

Recurrent restenosis previously treated with des stents

Data type

boolean

Alias
UMLS CUI [1,1]
C0333186
UMLS CUI [1,2]
C1961379
4. signs or symptoms of ischemia attributable to the target lesion, or stenosis > 50% by visual estimation of the lesion during angiography.
Description

Angiography

Data type

boolean

Alias
UMLS CUI [1]
C0002978
5. target lesion is located within a native coronary artery or bypass graft.
Description

Target lesion location

Data type

boolean

Alias
UMLS CUI [1]
C2986546
6. be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up.
Description

Protocol compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
7. able to understand and sign informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. confirmed pregnancy at the time of index pci.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
2. has known allergies to aspirin, and to both clopidogrel (plavix ®) and ticlopidine (ticlid ®).
Description

Hypersensitivity to aspirin, clopidogrel, ticlopidine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0040207
3. has known allergies or contraindication to heparin and bivalirudin (angiomax ®).
Description

Contraindication to heparin and bivalirudin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0019134
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0168273
4. has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
5. any serious disease condition with life expectancy of less than 1 year.
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. unsuccessful coronary revascularization procedure (residual stenosis > 30%).
Description

Coronary revascularization

Data type

boolean

Alias
UMLS CUI [1]
C0877341
7. angiographic evidence of thrombus.
Description

Angiographic evidence of thrombus

Data type

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0002971
8. no previous intracoronary radiation to the target artery.
Description

Intracoronary radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1522318
UMLS CUI [1,2]
C0851346

Similar models

Eligibility Coronary Artery Disease NCT00714545

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Percutaneous coronary intervention
Item
2. eligible for percutaneous coronary intervention.
boolean
C1532338 (UMLS CUI [1])
Recurrent restenosis previously treated with des stents
Item
3. target lesion with recurrent restenosis (>50% by visual estimate) previously treated with any 2 or more combination of des stents.
boolean
C0333186 (UMLS CUI [1,1])
C1961379 (UMLS CUI [1,2])
Angiography
Item
4. signs or symptoms of ischemia attributable to the target lesion, or stenosis > 50% by visual estimation of the lesion during angiography.
boolean
C0002978 (UMLS CUI [1])
Target lesion location
Item
5. target lesion is located within a native coronary artery or bypass graft.
boolean
C2986546 (UMLS CUI [1])
Protocol compliance
Item
6. be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up.
boolean
C0525058 (UMLS CUI [1])
Informed consent
Item
7. able to understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
1. confirmed pregnancy at the time of index pci.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity to aspirin, clopidogrel, ticlopidine
Item
2. has known allergies to aspirin, and to both clopidogrel (plavix ®) and ticlopidine (ticlid ®).
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
Contraindication to heparin and bivalirudin
Item
3. has known allergies or contraindication to heparin and bivalirudin (angiomax ®).
boolean
C1301624 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0168273 (UMLS CUI [2,2])
Comorbidity
Item
4. has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
boolean
C0009488 (UMLS CUI [1])
Life expectancy
Item
5. any serious disease condition with life expectancy of less than 1 year.
boolean
C0023671 (UMLS CUI [1])
Coronary revascularization
Item
6. unsuccessful coronary revascularization procedure (residual stenosis > 30%).
boolean
C0877341 (UMLS CUI [1])
Angiographic evidence of thrombus
Item
7. angiographic evidence of thrombus.
boolean
C0087086 (UMLS CUI [1,1])
C0002971 (UMLS CUI [1,2])
Intracoronary radiation
Item
8. no previous intracoronary radiation to the target artery.
boolean
C1522318 (UMLS CUI [1,1])
C0851346 (UMLS CUI [1,2])

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