ID

28719

Descripción

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III); ODM derived from: https://clinicaltrials.gov/show/NCT01078038

Link

https://clinicaltrials.gov/show/NCT01078038

Palabras clave

Versiones (1)
  1. 27/1/18 27/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT01078038

Inglés

Eligibility Coronary Artery Disease NCT01078038

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must be at least 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
Descripción

Coronary Artery Stenosis Native Percentage | Stenotic lesion length | Requirement Placement of stent Long Single | Requirement Placement of stent Long Multiple

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C1443266
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0522776
UMLS CUI [3,3]
C0205166
UMLS CUI [3,4]
C0205171
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0522776
UMLS CUI [4,3]
C0205166
UMLS CUI [4,4]
C0439064
patients with silent ischemia, stable or unstable angina pectoris, ad non-st-elevation myocardial infarction
Descripción

Silent myocardial ischemia | Stable angina | Angina, Unstable | Non-ST Elevated Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0340291
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C4255010
the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Descripción

Protocol Compliance | Informed Consent | Protocol Compliance Guardian | Informed Consent Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1274041
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
Descripción

Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Stainless Steel | Medical contraindication Contrast Media | Medical contraindication Sirolimus | Medical contraindication everolimus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0038126
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0009924
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0072980
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0541315
an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
Descripción

Elective Surgical Procedures Planned | Requirement Interruption Antiplatelet Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1512900
UMLS CUI [2,3]
C0085826
acute st-segment-elevation mi or cardiogenic shock
Descripción

ST segment elevation myocardial infarction | Shock, Cardiogenic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1536220
UMLS CUI [2]
C0036980
terminal illness with life expectancy <1 year
Descripción

Terminal illness | Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0023671
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0205257
in-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel isr is permitted)
Descripción

In Stent restenosis Target vessel | Bare metal stent segment | Drug-Eluting Stent segment | In Stent restenosis Vessel allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3272317
UMLS CUI [1,2]
C0449618
UMLS CUI [2,1]
C2825200
UMLS CUI [2,2]
C0441635
UMLS CUI [3,1]
C1322815
UMLS CUI [3,2]
C0441635
UMLS CUI [4,1]
C3272317
UMLS CUI [4,2]
C0005847
UMLS CUI [4,3]
C0683607
patients with ef<30%.
Descripción

Cardiac ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232174
serum creatinine level >=3.0mg/dl or dependence on dialysis.
Descripción

Creatinine measurement, serum | Dependence on renal dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0524376
patients with left main stem stenosis (>50% by visual estimate).
Descripción

Left main coronary artery stenosis Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2062905
UMLS CUI [1,2]
C0439165
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Similar models

Eligibility Coronary Artery Disease NCT01078038

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
the patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Stenosis Native Percentage | Stenotic lesion length | Requirement Placement of stent Long Single | Requirement Placement of stent Long Multiple
Item
significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
boolean
C0242231 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1443266 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0522776 (UMLS CUI [3,2])
C0205166 (UMLS CUI [3,3])
C0205171 (UMLS CUI [3,4])
C1514873 (UMLS CUI [4,1])
C0522776 (UMLS CUI [4,2])
C0205166 (UMLS CUI [4,3])
C0439064 (UMLS CUI [4,4])
Silent myocardial ischemia | Stable angina | Angina, Unstable | Non-ST Elevated Myocardial Infarction
Item
patients with silent ischemia, stable or unstable angina pectoris, ad non-st-elevation myocardial infarction
boolean
C0340291 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C4255010 (UMLS CUI [4])
Protocol Compliance | Informed Consent | Protocol Compliance Guardian | Informed Consent Guardian
Item
the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Stainless Steel | Medical contraindication Contrast Media | Medical contraindication Sirolimus | Medical contraindication everolimus
Item
any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0038126 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0009924 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0072980 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0541315 (UMLS CUI [7,2])
Elective Surgical Procedures Planned | Requirement Interruption Antiplatelet Agents
Item
an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
C0085826 (UMLS CUI [2,3])
ST segment elevation myocardial infarction | Shock, Cardiogenic
Item
acute st-segment-elevation mi or cardiogenic shock
boolean
C1536220 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
Terminal illness | Life Expectancy
Item
terminal illness with life expectancy <1 year
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete
Item
patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
In Stent restenosis Target vessel | Bare metal stent segment | Drug-Eluting Stent segment | In Stent restenosis Vessel allowed
Item
in-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel isr is permitted)
boolean
C3272317 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C2825200 (UMLS CUI [2,1])
C0441635 (UMLS CUI [2,2])
C1322815 (UMLS CUI [3,1])
C0441635 (UMLS CUI [3,2])
C3272317 (UMLS CUI [4,1])
C0005847 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Cardiac ejection fraction
Item
patients with ef<30%.
boolean
C0232174 (UMLS CUI [1])
Creatinine measurement, serum | Dependence on renal dialysis
Item
serum creatinine level >=3.0mg/dl or dependence on dialysis.
boolean
C0201976 (UMLS CUI [1])
C0524376 (UMLS CUI [2])
Left main coronary artery stenosis Percentage
Item
patients with left main stem stenosis (>50% by visual estimate).
boolean
C2062905 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
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