ID

28719

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01078038

Keywords

  1. 27/01/18 27/01/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

27 gennaio 2018

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT01078038

Eligibility Coronary Artery Disease NCT01078038

Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

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)
Descrizione

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

Tipo di dati

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
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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
Descrizione

Exclusion Criteria

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

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

Tipo di dati

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.
Descrizione

Elective Surgical Procedures Planned | Requirement Interruption Antiplatelet Agents

Tipo di dati

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
Descrizione

ST segment elevation myocardial infarction | Shock, Cardiogenic

Tipo di dati

boolean

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

Terminal illness | Life Expectancy

Tipo di dati

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.
Descrizione

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

Tipo di dati

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)
Descrizione

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

Tipo di dati

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%.
Descrizione

Cardiac ejection fraction

Tipo di dati

boolean

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

Creatinine measurement, serum | Dependence on renal dialysis

Tipo di dati

boolean

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

Left main coronary artery stenosis Percentage

Tipo di dati

boolean

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

Similar models

Eligibility Coronary Artery Disease NCT01078038

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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