ID

28751

Description

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

Keywords

Versions (1)
  1. 2/1/18 2/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 1, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00552656

English

Eligibility Coronary Disease NCT00552656

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Indication Intervention Coronary

Data type

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
Description

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

Data type

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)
Description

Reference Vessel Diameter Size

Data type

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)
Description

Stenosis Percentage Target Lesion

Data type

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 )
Description

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

Data type

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
Description

Follow-up Agreement | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Myocardial Infarction

Data type

boolean

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

Graft Lesion post CABG

Data type

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
Description

Drug-Eluting Stent Implants

Data type

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)
Description

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

Data type

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)
Description

Renal dysfunction | Creatinine measurement, serum

Data type

boolean

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

Intravascular brachytherapy Intervention preceding | Intervention Except PTCA

Data type

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
Description

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

Data type

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
Description

Life Expectancy

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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