ID

20490

Descripción

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

Palabras clave

Versiones (1)
  1. 25/2/17 25/2/17 -
Subido en

25 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00714545

Inglés

Eligibility Coronary Artery Disease NCT00714545

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Percutaneous coronary intervention

Tipo de datos

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.
Descripción

Recurrent restenosis previously treated with des stents

Tipo de datos

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.
Descripción

Angiography

Tipo de datos

boolean

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

Target lesion location

Tipo de datos

boolean

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

Protocol compliance

Tipo de datos

boolean

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

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Pregnancy

Tipo de datos

boolean

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

Hypersensitivity to aspirin, clopidogrel, ticlopidine

Tipo de datos

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 ®).
Descripción

Contraindication to heparin and bivalirudin

Tipo de datos

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.
Descripción

Comorbidity

Tipo de datos

boolean

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

Life expectancy

Tipo de datos

boolean

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

Coronary revascularization

Tipo de datos

boolean

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

Angiographic evidence of thrombus

Tipo de datos

boolean

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

Intracoronary radiation

Tipo de datos

boolean

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

Eligibility Coronary Artery Disease NCT00714545

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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