ID

35186

Description

SYNERGY China: Assess SYNERGY Stent in China; ODM derived from: https://clinicaltrials.gov/show/NCT02499692

Link

https://clinicaltrials.gov/show/NCT02499692

Keywords

Versions (1)
  1. 2/22/19 2/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Diseases NCT02499692

English

Eligibility Cardiovascular Diseases NCT02499692

1 forms  
Criteria
Description

Criteria

1. subject must be at least 18 -75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject is eligible for percutaneous coronary intervention (pci)
Description

Study Subject Eligible Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C1532338
3. target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥2.25 mm and ≤4.0 mm, length must be ≤34*
Description

Target Lesion Location Coronary artery | Reference Vessel Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205042
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
mm (by visual estimate), target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in myocardial infarction (timi) flow >1
Description

Target Lesion Stenosis Percentage | Thrombolysis in Myocardial Infarction Flow

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1261287
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C3272266
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. planned pci (including staged procedures) or cabg after the index procedure
Description

Percutaneous Coronary Intervention Planned | Surgery staged operation Included | Coronary Artery Bypass Surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C4027584
UMLS CUI [2,2]
C0332257
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C1301732
2. subject with out of range complete blood count (cbc) values that are determined by the study physician to be clinically significant.
Description

Complete Blood Count Out of range

Data type

boolean

Alias
UMLS CUI [1,1]
C0009555
UMLS CUI [1,2]
C3845292
3. subject is on dialysis or has baseline serum creatinine level >2.0 mg/dl (177µmol/l)
Description

Dialysis | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0201976
4. planned treatment of more than 3 lesions, planned treatment of lesions in more than 2 major epicardial vessels, planned treatment of a single lesion with more than 1 stent
Description

Therapeutic procedure Planned | Lesion Quantity | Lesion Blood Vessel Epicardial Quantity | Lesion Single Stent Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0005847
UMLS CUI [3,3]
C0442016
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0205171
UMLS CUI [4,3]
C0038257
UMLS CUI [4,4]
C1265611
5. target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate.
Description

Target Lesion Location Left anterior descending coronary artery | Target Lesion Location Left circumflex coronary artery

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0226032
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0226037
6. target vessel develops a dissection greater than national heart, lung, blood institute (nhlbi) type c following the pre-dilatation/pre-treatment of the first target lesion
Description

Target Lesion Dissection

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0012737
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Similar models

Eligibility Cardiovascular Diseases NCT02499692

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
1. subject must be at least 18 -75 years of age
boolean
C0001779 (UMLS CUI [1])
Study Subject Eligible Percutaneous Coronary Intervention
Item
2. subject is eligible for percutaneous coronary intervention (pci)
boolean
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Target Lesion Location Coronary artery | Reference Vessel Diameter
Item
3. target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥2.25 mm and ≤4.0 mm, length must be ≤34*
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
Target Lesion Stenosis Percentage | Thrombolysis in Myocardial Infarction Flow
Item
mm (by visual estimate), target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in myocardial infarction (timi) flow >1
boolean
C2986546 (UMLS CUI [1,1])
C1261287 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Planned | Surgery staged operation Included | Coronary Artery Bypass Surgery Planned
Item
1. planned pci (including staged procedures) or cabg after the index procedure
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C4027584 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Complete Blood Count Out of range
Item
2. subject with out of range complete blood count (cbc) values that are determined by the study physician to be clinically significant.
boolean
C0009555 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
Dialysis | Creatinine measurement, serum
Item
3. subject is on dialysis or has baseline serum creatinine level >2.0 mg/dl (177µmol/l)
boolean
C0011946 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Therapeutic procedure Planned | Lesion Quantity | Lesion Blood Vessel Epicardial Quantity | Lesion Single Stent Quantity
Item
4. planned treatment of more than 3 lesions, planned treatment of lesions in more than 2 major epicardial vessels, planned treatment of a single lesion with more than 1 stent
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C0442016 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0221198 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0038257 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Target Lesion Location Left anterior descending coronary artery | Target Lesion Location Left circumflex coronary artery
Item
5. target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0226032 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0226037 (UMLS CUI [2,3])
Target Lesion Dissection
Item
6. target vessel develops a dissection greater than national heart, lung, blood institute (nhlbi) type c following the pre-dilatation/pre-treatment of the first target lesion
boolean
C2986546 (UMLS CUI [1,1])
C0012737 (UMLS CUI [1,2])
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