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])
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])