ID

23955

Beschreibung

"JACTAX" Trial Drug Eluting Stent Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00754728

Link

https://clinicaltrials.gov/show/NCT00754728

Stichworte

Versionen (1)
  1. 19.07.17 19.07.17 -
Hochgeladen am

19. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00754728

Englisch

Eligibility Coronary Artery Disease NCT00754728

1 Formulare  
Criteria
Beschreibung

Criteria

1. patient is ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

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

Patient eligible Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C1532338
3. patient demonstrates lvef of ≥ 25%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
4. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect
Beschreibung

Protocol Compliance | Informed Consent | Protocol Compliance Legal Guardian | Informed Consent Legal Guardian

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0023226
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0023226
angiographic inclusion criteria:
Beschreibung

Inclusion criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
1. target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
Beschreibung

Target Lesion Identification | Coronary artery Lesion Native de novo

Datentyp

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0302891
UMLS CUI [2,4]
C1515568
2. target lesion can be treated with one stent, with overlap onto the healthy tissue, as specified in visual estimate guidelines.max lesion length is 20 mm(i.e. approximately 4mm on each side, based on visual estimate and available stent lengths)
Beschreibung

Therapeutic procedure Target Lesion Stent | Overlap Tissue Healthy | Lesion Length Maximal | Visual estimation | Length of stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0038257
UMLS CUI [2,1]
C0185027
UMLS CUI [2,2]
C0040300
UMLS CUI [2,3]
C3898900
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1444754
UMLS CUI [3,3]
C0205289
UMLS CUI [4]
C0444684
UMLS CUI [5]
C0449462
3. reference vessel diameter is between 2.75mm and 3.5 mm
Beschreibung

Reference Vessel Diameter size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
UMLS CUI [1,4]
C0456389
4. study lesion diameter stenosis is ≥70%
Beschreibung

Lesion Diameter Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1261287
UMLS CUI [1,4]
C0439165
5. study lesion has been successfully pre-dilated
Beschreibung

Lesion Pre-Dilation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1322279
UMLS CUI [1,3]
C0332152
6. patients enrolled for treatment may demonstrate multiple lesions in target vessel. however lesions must be covered completely by one study stent
Beschreibung

Multiple lesions Target vessel | Lesion Covered Stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577305
UMLS CUI [1,2]
C0449618
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0439844
UMLS CUI [2,3]
C0038257
7. patient must have no more than two lesions requiring treatment. these lesions must be in different vessel distributions. for example, if the target lesion is in the lad, then the non target lesion must be present in either the circumflex or rca. the non-study lesion may not be in a branch vessel or distal to the target vessel location
Beschreibung

Lesion Quantity Treatment required for | Lesion Vessel Distribution Different | Target Lesion Left anterior descending artery | Non-Target Lesion Circumflex artery | Non-Target Lesion Right coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1704711
UMLS CUI [2,4]
C1705242
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C0226032
UMLS CUI [4,1]
C2986547
UMLS CUI [4,2]
C0226037
UMLS CUI [5,1]
C2986547
UMLS CUI [5,2]
C0226042
8. the non target lesion must be successfully treated prior to the treatment of the target lesion. the non target lesion must be treated with either a taxus paclitaxel eluting stent or a bare metal stent.
Beschreibung

Therapeutic procedure Non-Target Lesion Paclitaxel drug-eluting stent | Therapeutic procedure Non-Target Lesion Bare metal stent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2986547
UMLS CUI [1,3]
C2199092
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2986547
UMLS CUI [2,3]
C2825200
general exclusion criteria:
Beschreibung

Exclusion Criteria General

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
1. the patient has a life expectancy of less than 24 months due to another medical condition
Beschreibung

Life Expectancy Due to other medical condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3843040
2. patient has a history of hypersensitivity to paclitaxel or structurally related compounds
Beschreibung

Paclitaxel allergy | Hypersensitivity Paclitaxel Compound Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0144576
UMLS CUI [2,3]
C1706082
UMLS CUI [2,4]
C0439849
3. patient exhibits cardiogenic shock (systolic pressure <80 mmhg and pcwp> 20mm hg or cardiac index <1.8 liters/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80 mmhg) for any time within 24 hours prior to index procedure
Beschreibung

Shock, Cardiogenic | Systolic Pressure | Pulmonary Capillary Wedge Pressure | Cardiac index | Intra-Aortic Balloon Pump | Inotropic agent Intravenous

Datentyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0086879
UMLS CUI [4]
C0428776
UMLS CUI [5]
C0021860
UMLS CUI [6,1]
C0304509
UMLS CUI [6,2]
C1522726
4. patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or 177umol/l)
Beschreibung

Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0201976
5. planned cardiac surgery procedure <= 9 months post index procedure
Beschreibung

Cardiac Surgery procedure Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
6. patient demonstrates evidence of a myocardial infarction (elevated ck, ckmb or troponin) within 72 hours prior to index procedure and/or ck> 2x local lab's uln, unless ck-mb is <2x uln
Beschreibung

Myocardial Infarction | Elevated creatine kinase | Increased CK-MB | Troponin increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0151576
UMLS CUI [3]
C1834663
UMLS CUI [4]
C1141948
7. patient exhibits acute st segment elevation mi (stemi) within 72 hours prior to the index procedure
Beschreibung

Acute ST segment elevation myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1303258
8. cva including stroke or tia within 3 months
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
9. patient demonstrates evidence of leukopenia
Beschreibung

Leukopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023530
10. patient demonstrates evidence of thrombocytopenia or thrombocytosis
Beschreibung

Thrombocytopenia | Thrombocytosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0836924
11. patient is contraindicated to asa, clopidogrel or ticlopidine
Beschreibung

Medical contraindication Aspirin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0040207
12. patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
Beschreibung

Warfarin | Warfarin Possible

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C0043031
UMLS CUI [2,2]
C0332149
13. patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
Beschreibung

Paclitaxel | Chemotherapeutic agent

Datentyp

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0729502
14. anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
Beschreibung

Paclitaxel Expected | Sirolimus Oral Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0072980
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1517001
15. patient has received a drug eluting stent within 12 months prior to planned index procedure
Beschreibung

Drug-Eluting Stent

Datentyp

boolean

Alias
UMLS CUI [1]
C1322815
16. previous or planned treatment with intravascular brachytherapy in target vessel
Beschreibung

Intravascular brachytherapy Target vessel | Intravascular brachytherapy Target vessel Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0994608
UMLS CUI [1,2]
C0449618
UMLS CUI [2,1]
C0994608
UMLS CUI [2,2]
C0449618
UMLS CUI [2,3]
C1301732
17. known allergy to stainless steel
Beschreibung

Hypersensitivity Stainless Steel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038126
18. male or female with known intention to procreate within 3 months after the index procedure
Beschreibung

Gender | Reproduction intended

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0035150
UMLS CUI [2,2]
C1283828
19. female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating or intends to become pregnant during the 12 months post index procedure
Beschreibung

Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
angiographic exclusion criteria
Beschreibung

Exclusion Criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0002978
1. evidence of probable or definite thrombus of the study vessel, based on angiography or ivus
Beschreibung

Thrombus Vessel Involved | Thrombus Probable Vessel Involved | Angiography | Ultrasonography, Intravascular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C1314939
UMLS CUI [3]
C0002978
UMLS CUI [4]
C0206520
2. study lesion is totally occluded (timi flow <= 1) either at baseline or before pre-dilatation
Beschreibung

Lesion Occluded Total | TIMI Flow

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1947917
UMLS CUI [1,3]
C0439810
UMLS CUI [2]
C3272266
3. study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
Beschreibung

Lesion Calcified Moderate | Lesion Calcified Severe | Vessel Proximal Calcified Moderate | Vessel Proximal Calcified Severe | Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0175895
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0005847
UMLS CUI [3,2]
C0205107
UMLS CUI [3,3]
C0175895
UMLS CUI [3,4]
C0205081
UMLS CUI [4,1]
C0005847
UMLS CUI [4,2]
C0205107
UMLS CUI [4,3]
C0175895
UMLS CUI [4,4]
C0205082
UMLS CUI [5]
C0444684
4. study lesion is ostial in location (within 3.0 mm of vessel origin)
Beschreibung

Lesion Ostium Location

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0444567
UMLS CUI [1,3]
C1515974
5. study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
Beschreibung

Lesion Segment Tortuous coronary artery | Lesion Location Vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0441635
UMLS CUI [1,3]
C1272586
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0005847
6. study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
Beschreibung

Lesion Involved Bifurcation | Vessel Diameter Stenotic Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0226027
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0333181
UMLS CUI [2,4]
C0439165
7. left main coronary artery disease (stenosis >50%) branch vessel > 2.0 mm in diameter
Beschreibung

Left main coronary artery disease | Stenosis Percentage Vessel Diameter

Datentyp

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C1301886
8. target lesion length >20 mm based on visual estimate by operator
Beschreibung

Target Lesion Length Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [1,3]
C0444684
9. target vessel diameter >3.5 mm based on visual estimate by operator
Beschreibung

Target vessel Diameter Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0444684
10. target vessel diameter <2.75 mm based on visual estimate by operator
Beschreibung

Target vessel Diameter Visual estimation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0444684
11. pre-treatment of the target lesion (excluding predilation) with another interventional device
Beschreibung

Pre treatment Target Lesion | Medical Device Interventional | Dilation Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C2986546
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C0184661
UMLS CUI [3,1]
C1322279
UMLS CUI [3,2]
C2828389
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00754728

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
1. patient is ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Patient eligible Percutaneous Coronary Intervention
Item
2. patient is eligible for percutaneous coronary intervention (pci)
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
3. patient demonstrates lvef of ≥ 25%
boolean
C0428772 (UMLS CUI [1])
Protocol Compliance | Informed Consent | Protocol Compliance Legal Guardian | Informed Consent Legal Guardian
Item
4. patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0023226 (UMLS CUI [4,2])
Inclusion criteria Angiography
Item
angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Target Lesion Identification | Coronary artery Lesion Native de novo
Item
1. target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
boolean
C2986546 (UMLS CUI [1])
C0205042 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0302891 (UMLS CUI [2,3])
C1515568 (UMLS CUI [2,4])
Therapeutic procedure Target Lesion Stent | Overlap Tissue Healthy | Lesion Length Maximal | Visual estimation | Length of stent
Item
2. target lesion can be treated with one stent, with overlap onto the healthy tissue, as specified in visual estimate guidelines.max lesion length is 20 mm(i.e. approximately 4mm on each side, based on visual estimate and available stent lengths)
boolean
C0087111 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0185027 (UMLS CUI [2,1])
C0040300 (UMLS CUI [2,2])
C3898900 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
C0205289 (UMLS CUI [3,3])
C0444684 (UMLS CUI [4])
C0449462 (UMLS CUI [5])
Reference Vessel Diameter size
Item
3. reference vessel diameter is between 2.75mm and 3.5 mm
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Lesion Diameter Stenosis Percentage
Item
4. study lesion diameter stenosis is ≥70%
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1261287 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Lesion Pre-Dilation
Item
5. study lesion has been successfully pre-dilated
boolean
C0221198 (UMLS CUI [1,1])
C1322279 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Multiple lesions Target vessel | Lesion Covered Stent
Item
6. patients enrolled for treatment may demonstrate multiple lesions in target vessel. however lesions must be covered completely by one study stent
boolean
C0577305 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0439844 (UMLS CUI [2,2])
C0038257 (UMLS CUI [2,3])
Lesion Quantity Treatment required for | Lesion Vessel Distribution Different | Target Lesion Left anterior descending artery | Non-Target Lesion Circumflex artery | Non-Target Lesion Right coronary artery
Item
7. patient must have no more than two lesions requiring treatment. these lesions must be in different vessel distributions. for example, if the target lesion is in the lad, then the non target lesion must be present in either the circumflex or rca. the non-study lesion may not be in a branch vessel or distal to the target vessel location
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1704711 (UMLS CUI [2,3])
C1705242 (UMLS CUI [2,4])
C2986546 (UMLS CUI [3,1])
C0226032 (UMLS CUI [3,2])
C2986547 (UMLS CUI [4,1])
C0226037 (UMLS CUI [4,2])
C2986547 (UMLS CUI [5,1])
C0226042 (UMLS CUI [5,2])
Therapeutic procedure Non-Target Lesion Paclitaxel drug-eluting stent | Therapeutic procedure Non-Target Lesion Bare metal stent
Item
8. the non target lesion must be successfully treated prior to the treatment of the target lesion. the non target lesion must be treated with either a taxus paclitaxel eluting stent or a bare metal stent.
boolean
C0087111 (UMLS CUI [1,1])
C2986547 (UMLS CUI [1,2])
C2199092 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C2986547 (UMLS CUI [2,2])
C2825200 (UMLS CUI [2,3])
Exclusion Criteria General
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Life Expectancy Due to other medical condition
Item
1. the patient has a life expectancy of less than 24 months due to another medical condition
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
Paclitaxel allergy | Hypersensitivity Paclitaxel Compound Related
Item
2. patient has a history of hypersensitivity to paclitaxel or structurally related compounds
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
Shock, Cardiogenic | Systolic Pressure | Pulmonary Capillary Wedge Pressure | Cardiac index | Intra-Aortic Balloon Pump | Inotropic agent Intravenous
Item
3. patient exhibits cardiogenic shock (systolic pressure <80 mmhg and pcwp> 20mm hg or cardiac index <1.8 liters/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80 mmhg) for any time within 24 hours prior to index procedure
boolean
C0036980 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0086879 (UMLS CUI [3])
C0428776 (UMLS CUI [4])
C0021860 (UMLS CUI [5])
C0304509 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum
Item
4. patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or 177umol/l)
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Cardiac Surgery procedure Planned
Item
5. planned cardiac surgery procedure <= 9 months post index procedure
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Myocardial Infarction | Elevated creatine kinase | Increased CK-MB | Troponin increased
Item
6. patient demonstrates evidence of a myocardial infarction (elevated ck, ckmb or troponin) within 72 hours prior to index procedure and/or ck> 2x local lab's uln, unless ck-mb is <2x uln
boolean
C0027051 (UMLS CUI [1])
C0151576 (UMLS CUI [2])
C1834663 (UMLS CUI [3])
C1141948 (UMLS CUI [4])
Acute ST segment elevation myocardial infarction
Item
7. patient exhibits acute st segment elevation mi (stemi) within 72 hours prior to the index procedure
boolean
C1303258 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
8. cva including stroke or tia within 3 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Leukopenia
Item
9. patient demonstrates evidence of leukopenia
boolean
C0023530 (UMLS CUI [1])
Thrombocytopenia | Thrombocytosis
Item
10. patient demonstrates evidence of thrombocytopenia or thrombocytosis
boolean
C0040034 (UMLS CUI [1])
C0836924 (UMLS CUI [2])
Medical contraindication Aspirin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine
Item
11. patient is contraindicated to asa, clopidogrel or ticlopidine
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0040207 (UMLS CUI [3,2])
Warfarin | Warfarin Possible
Item
12. patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
boolean
C0043031 (UMLS CUI [1])
C0043031 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Paclitaxel | Chemotherapeutic agent
Item
13. patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
boolean
C0144576 (UMLS CUI [1])
C0729502 (UMLS CUI [2])
Paclitaxel Expected | Sirolimus Oral Expected
Item
14. anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
boolean
C0144576 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0072980 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Drug-Eluting Stent
Item
15. patient has received a drug eluting stent within 12 months prior to planned index procedure
boolean
C1322815 (UMLS CUI [1])
Intravascular brachytherapy Target vessel | Intravascular brachytherapy Target vessel Planned
Item
16. previous or planned treatment with intravascular brachytherapy in target vessel
boolean
C0994608 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C0994608 (UMLS CUI [2,1])
C0449618 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Hypersensitivity Stainless Steel
Item
17. known allergy to stainless steel
boolean
C0020517 (UMLS CUI [1,1])
C0038126 (UMLS CUI [1,2])
Gender | Reproduction intended
Item
18. male or female with known intention to procreate within 3 months after the index procedure
boolean
C0079399 (UMLS CUI [1])
C0035150 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
19. female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating or intends to become pregnant during the 12 months post index procedure
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Exclusion Criteria Angiography
Item
angiographic exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Thrombus Vessel Involved | Thrombus Probable Vessel Involved | Angiography | Ultrasonography, Intravascular
Item
1. evidence of probable or definite thrombus of the study vessel, based on angiography or ivus
boolean
C0087086 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0087086 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C0002978 (UMLS CUI [3])
C0206520 (UMLS CUI [4])
Lesion Occluded Total | TIMI Flow
Item
2. study lesion is totally occluded (timi flow <= 1) either at baseline or before pre-dilatation
boolean
C0221198 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2])
Lesion Calcified Moderate | Lesion Calcified Severe | Vessel Proximal Calcified Moderate | Vessel Proximal Calcified Severe | Visual estimation
Item
3. study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0175895 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0005847 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C0175895 (UMLS CUI [3,3])
C0205081 (UMLS CUI [3,4])
C0005847 (UMLS CUI [4,1])
C0205107 (UMLS CUI [4,2])
C0175895 (UMLS CUI [4,3])
C0205082 (UMLS CUI [4,4])
C0444684 (UMLS CUI [5])
Lesion Ostium Location
Item
4. study lesion is ostial in location (within 3.0 mm of vessel origin)
boolean
C0221198 (UMLS CUI [1,1])
C0444567 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Lesion Segment Tortuous coronary artery | Lesion Location Vessel
Item
5. study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
boolean
C0221198 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C1272586 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
Lesion Involved Bifurcation | Vessel Diameter Stenotic Percentage
Item
6. study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
boolean
C0221198 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0226027 (UMLS CUI [1,3])
C0005847 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0333181 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Left main coronary artery disease | Stenosis Percentage Vessel Diameter
Item
7. left main coronary artery disease (stenosis >50%) branch vessel > 2.0 mm in diameter
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C1301886 (UMLS CUI [2,4])
Target Lesion Length Visual estimation
Item
8. target lesion length >20 mm based on visual estimate by operator
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
Target vessel Diameter Visual estimation
Item
9. target vessel diameter >3.5 mm based on visual estimate by operator
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
Target vessel Diameter Visual estimation
Item
10. target vessel diameter <2.75 mm based on visual estimate by operator
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0444684 (UMLS CUI [1,3])
Pre treatment Target Lesion | Medical Device Interventional | Dilation Excluded
Item
11. pre-treatment of the target lesion (excluding predilation) with another interventional device
boolean
C2709094 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0025080 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C1322279 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
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