ID

28751

Descripción

Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00552656

Link

https://clinicaltrials.gov/show/NCT00552656

Palabras clave

Versiones (1)
  1. 1/2/18 1/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00552656

Inglés

Eligibility Coronary Disease NCT00552656

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients who have the indication for coronary interventional therapy
Descripción

Indication Intervention Coronary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C1522318
stable angina pectoris (ccs class i ii iii iv)or unstable angina pectoris (braunwald class b＆c，i-ii) or documented asymptomatic myocardial ischemia
Descripción

Stable angina CCS classification of angina | Angina, Unstable | Other Coding | Myocardial Ischemia Asymptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0340288
UMLS CUI [1,2]
C1277207
UMLS CUI [2]
C0002965
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0151744
UMLS CUI [4,2]
C0231221
reference vessel diameter is of 2.5mm to 4.0mm (estimated by investigator)
Descripción

Reference Vessel Diameter Size

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
significant(>70%) stenosis of target lesion (estimated by investigator)
Descripción

Stenosis Percentage Target Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C2986546
angiographic criteria is complex coronary lesions which includes the followings: multivessel lesions(>or=two vessels), diffuse long lesions with length>or=30mm or need two stents overlapped, small vessel lesions(reference vessel diameter<or=2.5mm estimated by investigator), bifurcation lesions need one or two stents and side branch diameter>2.0mm, chronic total occlusion lesions(>3 months), ostial target lesions(including ostial of right coronary artery,left anterior descending artery and left circumflex artery), severe calcification or angulation(location of target lesion at a >45°bend), protected and unprotected left main lesions, restenosis after bare metal stent implantation(core laboratory decision )
Descripción

Angiography Criteria | Lesion Coronary Complex | Coronary Vessel Lesion Quantity | Diffuse Lesion Long Length | Stent Quantity Overlapped | Coronary Vessel Lesion Small | Reference Vessel Diameter Size | Chronic Total Occlusion Lesion | Target Lesion Ostium | Calcification Severe | Angulation Severe | Left main coronary artery Lesion | Restenosis post Bare metal coronary stent placement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002978
UMLS CUI [1,2]
C0243161
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1522318
UMLS CUI [2,3]
C0439855
UMLS CUI [3,1]
C3272304
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1707743
UMLS CUI [4,2]
C0205166
UMLS CUI [4,3]
C1444754
UMLS CUI [5,1]
C0038257
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0185027
UMLS CUI [6,1]
C3272304
UMLS CUI [6,2]
C0700321
UMLS CUI [7,1]
C1706462
UMLS CUI [7,2]
C0005847
UMLS CUI [7,3]
C1301886
UMLS CUI [7,4]
C0456389
UMLS CUI [8,1]
C3275069
UMLS CUI [8,2]
C0221198
UMLS CUI [9,1]
C2986546
UMLS CUI [9,2]
C0444567
UMLS CUI [10,1]
C0175895
UMLS CUI [10,2]
C0205082
UMLS CUI [11,1]
C0333179
UMLS CUI [11,2]
C0205082
UMLS CUI [12,1]
C1261082
UMLS CUI [12,2]
C0221198
UMLS CUI [13,1]
C0333186
UMLS CUI [13,2]
C0687676
UMLS CUI [13,3]
C2609297
the patients would like to accept the follow-up and sign the informed consent
Descripción

Follow-up Agreement | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0680240
UMLS CUI [2]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute myocardial infarction within the preceding one month
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
graft lesions after cabg
Descripción

Graft Lesion post CABG

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3899021
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0010055
implanted other drug-eluting stents at the same time except the designated one
Descripción

Drug-Eluting Stent Implants

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0021102
left ventricle dysfunction with ejection fraction<30%(evaluated by echocardiogram with simpson's double-chamber method)
Descripción

Ventricular Dysfunction, Left | Cardiac ejection fraction Echocardiography | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
UMLS CUI [3]
C3846158
renal dysfunction with serum creatinine level>or=2mg/dl(177umol/l)
Descripción

Renal dysfunction | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
pre-intervention with intravascular brachytherapy or other non-ptca techniques
Descripción

Intravascular brachytherapy Intervention preceding | Intervention Except PTCA

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0994608
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C2936173
contradictions or allergy to aspirin, heparin, clopidogrel,stainless steel and hypersensitive to contrast media
Descripción

Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Stainless Steel | Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Stainless Steel | Contrast media allergy

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]
C0004058
UMLS CUI [6]
C0571776
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0070166
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0038126
UMLS CUI [9]
C0570562
anticipated life span < 12 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
Descripción

Study Subject Participation Status Primary Endpoint Incomplete | Interference Clinical Trial Current

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2986535
UMLS CUI [1,3]
C0205257
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0521116
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Similar models

Eligibility Coronary Disease NCT00552656

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Indication Intervention Coronary
Item
the patients who have the indication for coronary interventional therapy
boolean
C3146298 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1522318 (UMLS CUI [1,3])
Stable angina CCS classification of angina | Angina, Unstable | Other Coding | Myocardial Ischemia Asymptomatic
Item
stable angina pectoris (ccs class i ii iii iv)or unstable angina pectoris (braunwald class b＆c，i-ii) or documented asymptomatic myocardial ischemia
boolean
C0340288 (UMLS CUI [1,1])
C1277207 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C0151744 (UMLS CUI [4,1])
C0231221 (UMLS CUI [4,2])
Reference Vessel Diameter Size
Item
reference vessel diameter is of 2.5mm to 4.0mm (estimated by investigator)
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Stenosis Percentage Target Lesion
Item
significant(>70%) stenosis of target lesion (estimated by investigator)
boolean
C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
Angiography Criteria | Lesion Coronary Complex | Coronary Vessel Lesion Quantity | Diffuse Lesion Long Length | Stent Quantity Overlapped | Coronary Vessel Lesion Small | Reference Vessel Diameter Size | Chronic Total Occlusion Lesion | Target Lesion Ostium | Calcification Severe | Angulation Severe | Left main coronary artery Lesion | Restenosis post Bare metal coronary stent placement
Item
angiographic criteria is complex coronary lesions which includes the followings: multivessel lesions(>or=two vessels), diffuse long lesions with length>or=30mm or need two stents overlapped, small vessel lesions(reference vessel diameter<or=2.5mm estimated by investigator), bifurcation lesions need one or two stents and side branch diameter>2.0mm, chronic total occlusion lesions(>3 months), ostial target lesions(including ostial of right coronary artery,left anterior descending artery and left circumflex artery), severe calcification or angulation(location of target lesion at a >45°bend), protected and unprotected left main lesions, restenosis after bare metal stent implantation(core laboratory decision )
boolean
C0002978 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1522318 (UMLS CUI [2,2])
C0439855 (UMLS CUI [2,3])
C3272304 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1707743 (UMLS CUI [4,1])
C0205166 (UMLS CUI [4,2])
C1444754 (UMLS CUI [4,3])
C0038257 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0185027 (UMLS CUI [5,3])
C3272304 (UMLS CUI [6,1])
C0700321 (UMLS CUI [6,2])
C1706462 (UMLS CUI [7,1])
C0005847 (UMLS CUI [7,2])
C1301886 (UMLS CUI [7,3])
C0456389 (UMLS CUI [7,4])
C3275069 (UMLS CUI [8,1])
C0221198 (UMLS CUI [8,2])
C2986546 (UMLS CUI [9,1])
C0444567 (UMLS CUI [9,2])
C0175895 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0333179 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C1261082 (UMLS CUI [12,1])
C0221198 (UMLS CUI [12,2])
C0333186 (UMLS CUI [13,1])
C0687676 (UMLS CUI [13,2])
C2609297 (UMLS CUI [13,3])
Follow-up Agreement | Informed Consent
Item
the patients would like to accept the follow-up and sign the informed consent
boolean
C3274571 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Myocardial Infarction
Item
acute myocardial infarction within the preceding one month
boolean
C0027051 (UMLS CUI [1])
Graft Lesion post CABG
Item
graft lesions after cabg
boolean
C3899021 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
Drug-Eluting Stent Implants
Item
implanted other drug-eluting stents at the same time except the designated one
boolean
C1322815 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Ventricular Dysfunction, Left | Cardiac ejection fraction Echocardiography | Other Coding
Item
left ventricle dysfunction with ejection fraction<30%(evaluated by echocardiogram with simpson's double-chamber method)
boolean
C0242698 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Renal dysfunction | Creatinine measurement, serum
Item
renal dysfunction with serum creatinine level>or=2mg/dl(177umol/l)
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Intravascular brachytherapy Intervention preceding | Intervention Except PTCA
Item
pre-intervention with intravascular brachytherapy or other non-ptca techniques
boolean
C0994608 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C2936173 (UMLS CUI [2,3])
Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication clopidogrel | Medical contraindication Stainless Steel | Aspirin allergy | Heparin allergy | Hypersensitivity clopidogrel | Hypersensitivity Stainless Steel | Contrast media allergy
Item
contradictions or allergy to aspirin, heparin, clopidogrel,stainless steel and hypersensitive to contrast media
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])
C0004058 (UMLS CUI [5])
C0571776 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0070166 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0038126 (UMLS CUI [8,2])
C0570562 (UMLS CUI [9])
Life Expectancy
Item
anticipated life span < 12 months
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status Primary Endpoint Incomplete | Interference Clinical Trial Current
Item
enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
boolean
C2348568 (UMLS CUI [1,1])
C2986535 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C0521102 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
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