ID

28725

Beschreibung

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV); ODM derived from: https://clinicaltrials.gov/show/NCT01186094

Link

https://clinicaltrials.gov/show/NCT01186094

Stichworte

Versionen (1)
  1. 29.01.18 29.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Januar 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Coronary Artery Disease NCT01186094

Englisch

Eligibility Coronary Artery Disease NCT01186094

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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)
Beschreibung

Coronary Artery Stenosis Native Percentage | Lesion Length | Requirement Placement of stent Long Single | Requirement Placement of stent Long multiple | Length of stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1444754
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
UMLS CUI [5]
C0449462
patients with silent ischemia, stable or unstable angina pectoris, ad non-st-elevation myocardial infarction
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Stainless Steel | Contrast media allergy | Hypersensitivity Sirolimus | Hypersensitivity everolimus

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0038126
UMLS CUI [5]
C0570562
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0072980
UMLS CUI [7,1]
C0020517
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.
Beschreibung

Elective Surgical Procedure Planned | Requirement Interruption Antiplatelet Agents

Datentyp

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
Beschreibung

ST segment elevation myocardial infarction | Shock, Cardiogenic

Datentyp

boolean

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

Terminal illness | Life Expectancy

Datentyp

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.
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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]
C0205394
UMLS CUI [4,4]
C0683607
patients with ef<30%.
Beschreibung

Cardiac ejection fraction

Datentyp

boolean

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

Creatinine measurement, serum | Dependence on renal dialysis

Datentyp

boolean

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

Left coronary artery main stem Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0226031
UMLS CUI [1,2]
C1261287
UMLS CUI [1,3]
C0439165
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01186094

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 | Lesion Length | Requirement Placement of stent Long Single | Requirement Placement of stent Long multiple | Length of stent
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])
C0221198 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
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])
C0449462 (UMLS CUI [5])
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)
Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Stainless Steel | Contrast media allergy | Hypersensitivity Sirolimus | Hypersensitivity everolimus
Item
any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038126 (UMLS CUI [4,2])
C0570562 (UMLS CUI [5])
C0020517 (UMLS CUI [6,1])
C0072980 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0541315 (UMLS CUI [7,2])
Elective Surgical Procedure 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 Other 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])
C0205394 (UMLS CUI [4,3])
C0683607 (UMLS CUI [4,4])
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 coronary artery main stem Stenosis Percentage
Item
patients with left main stem stenosis (>50% by visual estimate).
boolean
C0226031 (UMLS CUI [1,1])
C1261287 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video