Informações:
Falhas:
ID
14561
Descrição
An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II); ODM derived from: https://clinicaltrials.gov/show/NCT01202058
Link
https://clinicaltrials.gov/show/NCT01202058
Palavras-chave
Versões (1)
- 21/04/2016 21/04/2016 -
Transferido a
21 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Atherosclerotic Coronary Artery Disease NCT01202058
Eligibility Atherosclerotic Coronary Artery Disease NCT01202058
- StudyEvent: Eligibility
Similar models
Eligibility Atherosclerotic Coronary Artery Disease NCT01202058
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Coronary Arteriosclerosis | Indication Placement of stent
Item
subject has atherosclerotic coronary artery disease with an indication for stent implantation;
boolean
C0010054 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0522776 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,1])
C0522776 (UMLS CUI [2,2])
Target Lesion Identification | Stenosis | Hemodynamics
Item
target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) or a functional study documenting the hemodynamic relevance of the target lesion(s);
boolean
C2986546 (UMLS CUI [1])
C1261287 (UMLS CUI [2])
C0019010 (UMLS CUI [3])
C1261287 (UMLS CUI [2])
C0019010 (UMLS CUI [3])
Target Lesion Identification | Therapeutic procedure Stent
Item
all target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
boolean
C2986546 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
Age
Item
subject is ≥18 years of age;
boolean
C0001779 (UMLS CUI [1])
Informed Consent Approved By Ethics Committee
Item
subject must sign ethics committee approved informed consent prior to undergoing any study specific procedure;
boolean
C0021430 (UMLS CUI [1,1])
C1706842 (UMLS CUI [1,2])
C0085546 (UMLS CUI [1,3])
C1706842 (UMLS CUI [1,2])
C0085546 (UMLS CUI [1,3])
Compliance behavior Follow-up Schedules, Patient
Item
subject must be willing and able to comply with specified follow-up schedule.
boolean
C1321605 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0030703 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,2])
C0030703 (UMLS CUI [1,3])
Medical procedure Planned | concomitant disease | Antiplatelet therapy Modification
Item
planned medical procedures or concomitant disease requiring modification of dapt regimen within 6 months of enrollment into this study;
boolean
C0199171 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0243087 (UMLS CUI [2])
C1096021 (UMLS CUI [3,1])
C3840684 (UMLS CUI [3,2])
C1301732 (UMLS CUI [1,2])
C0243087 (UMLS CUI [2])
C1096021 (UMLS CUI [3,1])
C3840684 (UMLS CUI [3,2])
Childbearing Potential | Pregnancy test negative | Contraceptive methods | follow-up angiogram | Breast Feeding
Item
women of childbearing potential without negative pregnancy test within 7 days before enrollment or women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable or lactating women. for women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non-pregnancy and birth control is sufficient;
boolean
C3831118 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C1522577 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5])
C0427780 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C1522577 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5])
Study Subject Participation Status
Item
currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
boolean
C2348568 (UMLS CUI [1])