ID

35186

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02499692

Stichworte

Versionen (1)
  1. 22.02.19 22.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Cardiovascular Diseases NCT02499692

Englisch

Eligibility Cardiovascular Diseases NCT02499692

1 Formulare  
Criteria
Beschreibung

Criteria

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

Age

Datentyp

boolean

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

Study Subject Eligible Percutaneous Coronary Intervention

Datentyp

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*
Beschreibung

Target Lesion Location Coronary artery | Reference Vessel Diameter

Datentyp

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
Beschreibung

Target Lesion Stenosis Percentage | Thrombolysis in Myocardial Infarction Flow

Datentyp

boolean

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

Exclusion Criteria Main

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

Complete Blood Count Out of range

Datentyp

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)
Beschreibung

Dialysis | Creatinine measurement, serum

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Target Lesion Dissection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0012737
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Ähnliche Modelle

Eligibility Cardiovascular Diseases NCT02499692

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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