ID

14995

Descrizione

The Asahi Intecc PTCA Chronic Total Occlusion Study; ODM derived from: https://clinicaltrials.gov/show/NCT02379923

collegamento

https://clinicaltrials.gov/show/NCT02379923

Keywords

versioni (1)
  1. 11/05/16 11/05/16 -
Caricato su

11 maggio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02379923

Inglese

Eligibility Coronary Artery Disease NCT02379923

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria:
Descrizione

Inclusion General

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. subject is ≥ 18 years of age at the time of consent
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the cto target vessel and is scheduled for clinically indicated percutaneous revascularization
Descrizione

Myocardial Ischemia Symptoms | Chest Pain | Chest discomfort | Heart failure | Myocardial Ischemia | Chronic Total Occlusion Target vessel | Indicated Percutaneous Coronary Revascularization

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0008031
UMLS CUI [3]
C0235710
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0151744
UMLS CUI [6,1]
C3275069
UMLS CUI [6,2]
C0449618
UMLS CUI [7,1]
C1444656
UMLS CUI [7,2]
C1532338
3. subject is eligible and consents to undergo pci procedure
Descrizione

Patient eligible for clinical trial | Consent Percutaneous Coronary Intervention

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1302261
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C1532338
4. subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergency coronary artery bypass grafting (cabg)
Descrizione

Percutaneous Transluminal Coronary Angioplasty | Coronary artery stent | Emergency CABG | Human Study Subject Acceptable

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2936173
UMLS CUI [2]
C0687568
UMLS CUI [3]
C1532296
UMLS CUI [4,1]
C2349001
UMLS CUI [4,2]
C1879533
5. subject is willing and able to sign an informed consent form approved by a local institutional review board
Descrizione

Informed Consent | Institutional Review Board Approval

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2346499
6. female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure
Descrizione

Childbearing Potential | Pregnancy test negative Qualitative | Pregnancy test negative Quantitative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0427780
UMLS CUI [2,2]
C0205556
UMLS CUI [3,1]
C0427780
UMLS CUI [3,2]
C0392762
angiographic inclusion criteria:
Descrizione

Inclusion | Coronary angiography

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0085532
7. a minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. non-study lesions will be treated first. a "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (timi 0 or 1) and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram. an attempt to cross the target lesion with at least one asahi guidewire or a corsair microcatheter must be made.
Descrizione

de novo Lesion | Target Lesion Identification | Coronary Vessels Native | Chronic Total Occlusion Vessel | native coronary artery stenosis Severe | Thrombolysis in Myocardial Infarction Flow-0 | Thrombolysis in Myocardial Infarction Flow-1 | angiogram | Electrocardiogram | Guidewire Across Lesion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1515568
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C2986546
UMLS CUI [3,1]
C0010075
UMLS CUI [3,2]
C0302891
UMLS CUI [4]
C3275069
UMLS CUI [5,1]
C2957458
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C3272284
UMLS CUI [7]
C3272285
UMLS CUI [8]
C0002978
UMLS CUI [9]
C0013798
UMLS CUI [10]
C3272318
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria:
Descrizione

Exclusion Criteria General

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
1. subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically
Descrizione

Hypersensitivity iodinated contrast dye

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0879373
2. evidence of acute mi within 72 hours of the intended treatment defined as cardiac enzymes greater than uln.
Descrizione

Myocardial Infarction | Cardiac enzymes | Upper Limit of Normal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0443763
UMLS CUI [3]
C1519815
3. previous coronary interventional procedure of any kind within the 30 days prior to the procedure
Descrizione

History of percutaneous coronary intervention

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1320647
4. any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and pci (e.g., aspirin, clopidogrel, unfractionated heparin, etc.)
Descrizione

Medical contraindication Cardiac Catheterization Procedures Concomitant Therapy Percutaneous Coronary Intervention | Aspirin | clopidogrel | Heparin

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0018795
UMLS CUI [1,3]
C1707479
UMLS CUI [1,4]
C1532338
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0019134
5. target lesion requires treatment with a device after successful crossing other than ptca prior to stent placement
Descrizione

Target Lesion Identification Requirement Therapeutic procedure Medical Device | Percutaneous Transluminal Coronary Angioplasty | Placement of stent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0025080
UMLS CUI [2]
C2936173
UMLS CUI [3]
C0522776
6. subjects with known history of clinically significant abnormal laboratory findings including:
Descrizione

Laboratory test result abnormal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0438215
neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks
Descrizione

Neutropenia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027947
thrombocytopenia (<100,000 platelets/mm3)
Descrizione

Thrombocytopenia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040034
ast, alt, alkaline phosphatase, or bilirubin > 1.5 × uln
Descrizione

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Upper Limit of Normal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
UMLS CUI [5]
C1519815
serum creatinine > 2.0 mg/dl
Descrizione

Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
7. subjects with evidence of ongoing or active clinical instability including the following:
Descrizione

Instability Clinical

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0205210
sustained systolic blood pressure < 100 mmhg or cardiogenic shock
Descrizione

Systolic Pressure | Shock, Cardiogenic

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0036980
acute pulmonary edema or severe congestive heart failure
Descrizione

Acute pulmonary edema | Congestive heart failure Severe

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0155919
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205082
suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
Descrizione

Acute myocarditis | Acute pericarditis | Acute endocarditis | Cardiac Tamponade

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0155686
UMLS CUI [2]
C0155679
UMLS CUI [3]
C0375268
UMLS CUI [4]
C0007177
suspected dissecting aortic aneurysm
Descrizione

Dissecting aortic aneurysm

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0012736
hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
Descrizione

Heart valve disease | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Congenital heart disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2]
C0007194
UMLS CUI [3]
C0007196
UMLS CUI [4]
C0152021
8. history of stroke or transient ischemic attack within the prior 6 months
Descrizione

Cerebrovascular accident | Transient Ischemic Attack

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
9. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
Descrizione

Peptic Ulcer | Upper gastrointestinal hemorrhage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
10. history of bleeding diathesis or coagulopathy or refusal of blood transfusions
Descrizione

Blood Coagulation Disorders | transfusion blood refusal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0749628
11. subjects with any other pathology such as cancer, mental illness, etc., which in the opinion of the investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
Descrizione

Comorbidity Affecting Patient safety Follow-up Research results | Malignant Neoplasms | Mental disorders

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [1,4]
C1522577
UMLS CUI [1,5]
C0683954
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0004936
12. known previous medical condition yielding expected survival less than 1 year
Descrizione

medical condition | Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1699700
UMLS CUI [2]
C0023671
13. subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
Descrizione

Compliance behavior Limited

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
14. currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (ivus), or other coronary artery imaging procedures
Descrizione

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Coronary angiography | Intravascular ultrasound | Coronary artery Imaging Techniques

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4]
C0085532
UMLS CUI [5]
C1456025
UMLS CUI [6,1]
C0205042
UMLS CUI [6,2]
C0079595
angiographic exclusion criteria:
Descrizione

Exclusion Criteria | Coronary angiography

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0085532
15. occlusion involves segment within previous stent
Descrizione

Occlusion Segment Previous stent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1955779
UMLS CUI [1,2]
C0441635
UMLS CUI [1,3]
C2114504
16. extensive lesion-related thrombus (timi thrombus grade 3 or 4)
Descrizione

Thrombus Extensive | Lesion | TIMI Thrombus Grade - Coronary Thrombus TIMI Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0205231
UMLS CUI [2]
C0221198
UMLS CUI [3]
C3897387
17. previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
Descrizione

previous stent placement | Drug-Eluting Stents | Bare metal stent | Target vessel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2114504
UMLS CUI [2]
C1322815
UMLS CUI [3]
C2825200
UMLS CUI [4]
C0449618
it has been at least 9 months since the previous stenting
Descrizione

Time Since Previous stent placement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C2114504
that target lesion is at least 15 mm away from the previously placed stent
Descrizione

Target Lesion Identification | Previous stent placement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2]
C2114504
the previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis, based on visual estimate
Descrizione

Previous stent placement Segment | Percent Diameter Stenosis Measurement Visual estimation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2114504
UMLS CUI [1,2]
C0441635
UMLS CUI [2,1]
C3897965
UMLS CUI [2,2]
C0444684
18. the target vessel has other lesions proximal to the total occlusion identified with greater than 75% diameter stenosis based on visual estimate. however, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (i.e., tandem lesions) are acceptable.
Descrizione

Target vessel | Lesion | Complete occlusion of coronary artery | Percent Diameter Stenosis Measurement Visual estimation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0449618
UMLS CUI [2]
C0221198
UMLS CUI [3]
C1955780
UMLS CUI [4,1]
C3897965
UMLS CUI [4,2]
C0444684
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Similar models

Eligibility Coronary Artery Disease NCT02379923

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion General
Item
general inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
1. subject is ≥ 18 years of age at the time of consent
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia Symptoms | Chest Pain | Chest discomfort | Heart failure | Myocardial Ischemia | Chronic Total Occlusion Target vessel | Indicated Percutaneous Coronary Revascularization
Item
2. subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the cto target vessel and is scheduled for clinically indicated percutaneous revascularization
boolean
C0151744 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0008031 (UMLS CUI [2])
C0235710 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0151744 (UMLS CUI [5])
C3275069 (UMLS CUI [6,1])
C0449618 (UMLS CUI [6,2])
C1444656 (UMLS CUI [7,1])
C1532338 (UMLS CUI [7,2])
Patient eligible for clinical trial | Consent Percutaneous Coronary Intervention
Item
3. subject is eligible and consents to undergo pci procedure
boolean
C1302261 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C1532338 (UMLS CUI [2,2])
Percutaneous Transluminal Coronary Angioplasty | Coronary artery stent | Emergency CABG | Human Study Subject Acceptable
Item
4. subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (ptca), stenting, and emergency coronary artery bypass grafting (cabg)
boolean
C2936173 (UMLS CUI [1])
C0687568 (UMLS CUI [2])
C1532296 (UMLS CUI [3])
C2349001 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
Informed Consent | Institutional Review Board Approval
Item
5. subject is willing and able to sign an informed consent form approved by a local institutional review board
boolean
C0021430 (UMLS CUI [1])
C2346499 (UMLS CUI [2])
Childbearing Potential | Pregnancy test negative Qualitative | Pregnancy test negative Quantitative
Item
6. female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure
boolean
C3831118 (UMLS CUI [1])
C0427780 (UMLS CUI [2,1])
C0205556 (UMLS CUI [2,2])
C0427780 (UMLS CUI [3,1])
C0392762 (UMLS CUI [3,2])
Inclusion | Coronary angiography
Item
angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
C0085532 (UMLS CUI [2])
de novo Lesion | Target Lesion Identification | Coronary Vessels Native | Chronic Total Occlusion Vessel | native coronary artery stenosis Severe | Thrombolysis in Myocardial Infarction Flow-0 | Thrombolysis in Myocardial Infarction Flow-1 | angiogram | Electrocardiogram | Guidewire Across Lesion
Item
7. a minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. non-study lesions will be treated first. a "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (timi 0 or 1) and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram. an attempt to cross the target lesion with at least one asahi guidewire or a corsair microcatheter must be made.
boolean
C1515568 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2])
C0010075 (UMLS CUI [3,1])
C0302891 (UMLS CUI [3,2])
C3275069 (UMLS CUI [4])
C2957458 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3272284 (UMLS CUI [6])
C3272285 (UMLS CUI [7])
C0002978 (UMLS CUI [8])
C0013798 (UMLS CUI [9])
C3272318 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria General
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Hypersensitivity iodinated contrast dye
Item
1. subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically
boolean
C0020517 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
Myocardial Infarction | Cardiac enzymes | Upper Limit of Normal
Item
2. evidence of acute mi within 72 hours of the intended treatment defined as cardiac enzymes greater than uln.
boolean
C0027051 (UMLS CUI [1])
C0443763 (UMLS CUI [2])
C1519815 (UMLS CUI [3])
History of percutaneous coronary intervention
Item
3. previous coronary interventional procedure of any kind within the 30 days prior to the procedure
boolean
C1320647 (UMLS CUI [1])
Medical contraindication Cardiac Catheterization Procedures Concomitant Therapy Percutaneous Coronary Intervention | Aspirin | clopidogrel | Heparin
Item
4. any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and pci (e.g., aspirin, clopidogrel, unfractionated heparin, etc.)
boolean
C1301624 (UMLS CUI [1,1])
C0018795 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,4])
C0004057 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0019134 (UMLS CUI [4])
Target Lesion Identification Requirement Therapeutic procedure Medical Device | Percutaneous Transluminal Coronary Angioplasty | Placement of stent
Item
5. target lesion requires treatment with a device after successful crossing other than ptca prior to stent placement
boolean
C2986546 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0025080 (UMLS CUI [1,4])
C2936173 (UMLS CUI [2])
C0522776 (UMLS CUI [3])
Laboratory test result abnormal
Item
6. subjects with known history of clinically significant abnormal laboratory findings including:
boolean
C0438215 (UMLS CUI [1])
Neutropenia
Item
neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks
boolean
C0027947 (UMLS CUI [1])
Thrombocytopenia
Item
thrombocytopenia (<100,000 platelets/mm3)
boolean
C0040034 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Upper Limit of Normal
Item
ast, alt, alkaline phosphatase, or bilirubin > 1.5 × uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1519815 (UMLS CUI [5])
Creatinine measurement, serum
Item
serum creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Instability Clinical
Item
7. subjects with evidence of ongoing or active clinical instability including the following:
boolean
C1444783 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Systolic Pressure | Shock, Cardiogenic
Item
sustained systolic blood pressure < 100 mmhg or cardiogenic shock
boolean
C0871470 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
Acute pulmonary edema | Congestive heart failure Severe
Item
acute pulmonary edema or severe congestive heart failure
boolean
C0155919 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Acute myocarditis | Acute pericarditis | Acute endocarditis | Cardiac Tamponade
Item
suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
boolean
C0155686 (UMLS CUI [1])
C0155679 (UMLS CUI [2])
C0375268 (UMLS CUI [3])
C0007177 (UMLS CUI [4])
Dissecting aortic aneurysm
Item
suspected dissecting aortic aneurysm
boolean
C0012736 (UMLS CUI [1])
Heart valve disease | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Congenital heart disease
Item
hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
boolean
C0018824 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0007196 (UMLS CUI [3])
C0152021 (UMLS CUI [4])
Cerebrovascular accident | Transient Ischemic Attack
Item
8. history of stroke or transient ischemic attack within the prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Peptic Ulcer | Upper gastrointestinal hemorrhage
Item
9. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
Blood Coagulation Disorders | transfusion blood refusal
Item
10. history of bleeding diathesis or coagulopathy or refusal of blood transfusions
boolean
C0005779 (UMLS CUI [1])
C0749628 (UMLS CUI [2])
Comorbidity Affecting Patient safety Follow-up Research results | Malignant Neoplasms | Mental disorders
Item
11. subjects with any other pathology such as cancer, mental illness, etc., which in the opinion of the investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])
C0683954 (UMLS CUI [1,5])
C0006826 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
medical condition | Life Expectancy
Item
12. known previous medical condition yielding expected survival less than 1 year
boolean
C1699700 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Compliance behavior Limited
Item
13. subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Coronary angiography | Intravascular ultrasound | Coronary artery Imaging Techniques
Item
14. currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (ivus), or other coronary artery imaging procedures
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0085532 (UMLS CUI [4])
C1456025 (UMLS CUI [5])
C0205042 (UMLS CUI [6,1])
C0079595 (UMLS CUI [6,2])
Exclusion Criteria | Coronary angiography
Item
angiographic exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
C0085532 (UMLS CUI [2])
Occlusion Segment Previous stent
Item
15. occlusion involves segment within previous stent
boolean
C1955779 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C2114504 (UMLS CUI [1,3])
Thrombus Extensive | Lesion | TIMI Thrombus Grade - Coronary Thrombus TIMI Grade
Item
16. extensive lesion-related thrombus (timi thrombus grade 3 or 4)
boolean
C0087086 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2])
C3897387 (UMLS CUI [3])
previous stent placement | Drug-Eluting Stents | Bare metal stent | Target vessel
Item
17. previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
boolean
C2114504 (UMLS CUI [1])
C1322815 (UMLS CUI [2])
C2825200 (UMLS CUI [3])
C0449618 (UMLS CUI [4])
Time Since Previous stent placement
Item
it has been at least 9 months since the previous stenting
boolean
C0040223 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C2114504 (UMLS CUI [1,3])
Target Lesion Identification | Previous stent placement
Item
that target lesion is at least 15 mm away from the previously placed stent
boolean
C2986546 (UMLS CUI [1])
C2114504 (UMLS CUI [2])
Previous stent placement Segment | Percent Diameter Stenosis Measurement Visual estimation
Item
the previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis, based on visual estimate
boolean
C2114504 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C3897965 (UMLS CUI [2,1])
C0444684 (UMLS CUI [2,2])
Target vessel | Lesion | Complete occlusion of coronary artery | Percent Diameter Stenosis Measurement Visual estimation
Item
18. the target vessel has other lesions proximal to the total occlusion identified with greater than 75% diameter stenosis based on visual estimate. however, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (i.e., tandem lesions) are acceptable.
boolean
C0449618 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C1955780 (UMLS CUI [3])
C3897965 (UMLS CUI [4,1])
C0444684 (UMLS CUI [4,2])
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