ID

35607

Description

Comparison of Double Kissing Culotte Stenting With Double Kissing Crush Stenting for True Bifurcation Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT01735656

Link

https://clinicaltrials.gov/show/NCT01735656

Keywords

Versions (1)
  1. 3/12/19 3/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT01735656

English

Eligibility Coronary Heart Disease NCT01735656

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with age of ≥18 and ≤80 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with stable or unstable angina, or nstemi.
Description

Stable angina | Angina, Unstable | NSTEMI

Data type

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1561921
3. de novo true bifurcation lesions (medina 0,1,1/1,1,1/1,0,1); mv diameter ≥2.5mm and sb diameter ≥2.25.
Description

Bifurcation lesion of coronary artery de novo Classification | Vessel Main Diameter | Side Branch Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0008902
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0441987
UMLS CUI [3,2]
C1253959
UMLS CUI [3,3]
C1301886
4. lesions suitable for pci (the syntax score <32 if lesions located at lm bifurcation).
Description

Lesion Amenable Percutaneous Coronary Intervention | Score Angiography | Lesion Location Left Main Coronary Artery Bifurcation

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C0002978
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C3898614
5. patients willing to receive all protocol-required evaluations.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
6. patients completely understand the trial requirements and treatment procedures and provide written informed consent before any trial-specific tests or procedures are performed.
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with stemi (within 24-hour from the onset of chest pain to admission).
Description

ST segment elevation myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1536220
2. lesions not suitable for pci (the syntax score ≥32 if lesions located at lm bifurcation, or any pci-related contraindications including patient conditions and/or lesion characteristics).
Description

Lesion Inappropriate Percutaneous Coronary Intervention | Score Angiography | Lesion Location Left Main Coronary Artery Bifurcation | Medical contraindication Relationship Percutaneous Coronary Intervention | Patient condition | Lesion Characteristics

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0449820
UMLS CUI [2,2]
C0002978
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C3898614
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C1532338
UMLS CUI [5]
C0683521
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C1521970
3. a chronic total occlusion lesion involved in bifurcation
Description

Chronic total occlusion Lesion | Involvement with Bifurcation

Data type

boolean

Alias
UMLS CUI [1,1]
C1955779
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C3146289
4. lesion with severe calcification that required for rotational atherectomy.
Description

Lesion Calcification Severe | Requirement Rotational Atherectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0162655
5. patients intolerable to long-term dual anti-platelet therapy.
Description

Antiplatelet therapy Dual Long-term Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C0205173
UMLS CUI [1,3]
C0443252
UMLS CUI [1,4]
C1299582
6. patients with obvious hematopoietic disorders (e.g., platelet count< 100×10^9/l or >700×10^9/l, leukocyte count<3×10^9/l).
Description

Disease Hematopoietic | Platelet Count measurement | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0229601
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0023508
7. patients with active bleeding and obviously hemorrhagic tendency (e.g., active ulcer, recent ischemic stroke, previous hemorrhagic stroke, intracranial malignant tumors, recent craniocerebral trauma, or any other active bleeding or hemorrhagic tendency with difficult hemostasis
Description

Hemorrhage | Bleeding tendency | Ulcer | Ischemic stroke | Brain hemorrhage | Malignant Intracranial Neoplasm | Craniocerebral Trauma | Hemostasis Difficult

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0041582
UMLS CUI [4]
C0948008
UMLS CUI [5]
C0553692
UMLS CUI [6]
C1334593
UMLS CUI [7]
C0018674
UMLS CUI [8,1]
C0019116
UMLS CUI [8,2]
C0332218
8. patients with serious renal insufficiency (scr<30ml/min) or hepatic insufficiency (alt≧3 times of normal upper limit), heart failure (nyha class >iii class).
Description

Renal Insufficiency Serious | Creatinine measurement, serum | Hepatic Insufficiency | Alanine aminotransferase increased | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1306571
UMLS CUI [4]
C0151905
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1275491
9. patients with any other serious medical illness that life expectancy is less than 12 months.
Description

Illness Serious | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0023671
10. woman with pregnancy or planning to pregnancy
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
11. patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
Description

Hypersensitivity Stenting Investigational | Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Hypersensitivity Zotarolimus | Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2348535
UMLS CUI [1,3]
C1517586
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0541315
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1700035
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013230
12. patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.
Description

Procedure Planned | Protocol Compliance Lacking | Interference Interpretation Research data

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0459471
UMLS CUI [3,3]
C0681873
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Similar models

Eligibility Coronary Heart Disease NCT01735656

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients with age of ≥18 and ≤80 years old.
boolean
C0001779 (UMLS CUI [1])
Stable angina | Angina, Unstable | NSTEMI
Item
2. patients with stable or unstable angina, or nstemi.
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1561921 (UMLS CUI [3])
Bifurcation lesion of coronary artery de novo Classification | Vessel Main Diameter | Side Branch Diameter
Item
3. de novo true bifurcation lesions (medina 0,1,1/1,1,1/1,0,1); mv diameter ≥2.5mm and sb diameter ≥2.25.
boolean
C1299363 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C0005847 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0441987 (UMLS CUI [3,1])
C1253959 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
Lesion Amenable Percutaneous Coronary Intervention | Score Angiography | Lesion Location Left Main Coronary Artery Bifurcation
Item
4. lesions suitable for pci (the syntax score <32 if lesions located at lm bifurcation).
boolean
C0221198 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0449820 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C3898614 (UMLS CUI [3,3])
Protocol Compliance
Item
5. patients willing to receive all protocol-required evaluations.
boolean
C0525058 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
6. patients completely understand the trial requirements and treatment procedures and provide written informed consent before any trial-specific tests or procedures are performed.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
ST segment elevation myocardial infarction
Item
1. patients with stemi (within 24-hour from the onset of chest pain to admission).
boolean
C1536220 (UMLS CUI [1])
Lesion Inappropriate Percutaneous Coronary Intervention | Score Angiography | Lesion Location Left Main Coronary Artery Bifurcation | Medical contraindication Relationship Percutaneous Coronary Intervention | Patient condition | Lesion Characteristics
Item
2. lesions not suitable for pci (the syntax score ≥32 if lesions located at lm bifurcation, or any pci-related contraindications including patient conditions and/or lesion characteristics).
boolean
C0221198 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0449820 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C3898614 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C1532338 (UMLS CUI [4,3])
C0683521 (UMLS CUI [5])
C0221198 (UMLS CUI [6,1])
C1521970 (UMLS CUI [6,2])
Chronic total occlusion Lesion | Involvement with Bifurcation
Item
3. a chronic total occlusion lesion involved in bifurcation
boolean
C1955779 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C3146289 (UMLS CUI [2,2])
Lesion Calcification Severe | Requirement Rotational Atherectomy
Item
4. lesion with severe calcification that required for rotational atherectomy.
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0162655 (UMLS CUI [2,2])
Antiplatelet therapy Dual Long-term Unable
Item
5. patients intolerable to long-term dual anti-platelet therapy.
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Disease Hematopoietic | Platelet Count measurement | White Blood Cell Count procedure
Item
6. patients with obvious hematopoietic disorders (e.g., platelet count< 100×10^9/l or >700×10^9/l, leukocyte count<3×10^9/l).
boolean
C0012634 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Hemorrhage | Bleeding tendency | Ulcer | Ischemic stroke | Brain hemorrhage | Malignant Intracranial Neoplasm | Craniocerebral Trauma | Hemostasis Difficult
Item
7. patients with active bleeding and obviously hemorrhagic tendency (e.g., active ulcer, recent ischemic stroke, previous hemorrhagic stroke, intracranial malignant tumors, recent craniocerebral trauma, or any other active bleeding or hemorrhagic tendency with difficult hemostasis
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0041582 (UMLS CUI [3])
C0948008 (UMLS CUI [4])
C0553692 (UMLS CUI [5])
C1334593 (UMLS CUI [6])
C0018674 (UMLS CUI [7])
C0019116 (UMLS CUI [8,1])
C0332218 (UMLS CUI [8,2])
Renal Insufficiency Serious | Creatinine measurement, serum | Hepatic Insufficiency | Alanine aminotransferase increased | Heart failure New York Heart Association Classification
Item
8. patients with serious renal insufficiency (scr<30ml/min) or hepatic insufficiency (alt≧3 times of normal upper limit), heart failure (nyha class >iii class).
boolean
C1565489 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0018801 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
Illness Serious | Life Expectancy
Item
9. patients with any other serious medical illness that life expectancy is less than 12 months.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
10. woman with pregnancy or planning to pregnancy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Hypersensitivity Stenting Investigational | Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Hypersensitivity Zotarolimus | Hypersensitivity Investigational New Drugs
Item
11. patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications
boolean
C0020517 (UMLS CUI [1,1])
C2348535 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0541315 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1700035 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
Procedure Planned | Protocol Compliance Lacking | Interference Interpretation Research data
Item
12. patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.
boolean
C0184661 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0459471 (UMLS CUI [3,2])
C0681873 (UMLS CUI [3,3])
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