ID

28501

Beskrivning

JACTAX LD Drug Eluting Stent Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00754975

Länk

https://clinicaltrials.gov/show/NCT00754975

Nyckelord

Versioner (1)
  1. 2018-01-20 2018-01-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00754975

Engelsk

Eligibility Coronary Artery Disease NCT00754975

1 Formulär  
Criteria
Beskrivning

Criteria

1. patient is ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient with coronary artery disease, eligible for percutaneous coronary intervention (pci)
Beskrivning

Coronary Artery Disease | Patient eligible Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C1532338
3. patient demonstrates a lvef of ≥ 25%
Beskrivning

Left ventricular ejection fraction

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Inclusion criteria Angiography

Datatyp

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)
Beskrivning

Target Lesion Identification | Lesion de novo Coronary artery Native

Datatyp

boolean

Alias
UMLS CUI [1]
C2986546
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C0205042
UMLS CUI [2,4]
C0302891
2. the target lesion can be treated with a maximum of one stent, with adequate coverage onto the healthy tissue, as specified in visual estimate guidelines. maximum lesion length is 20mm.
Beskrivning

Stent Quantity Maximum Target Lesion | Lesion Length Maximum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C2986546
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1444754
UMLS CUI [2,3]
C0806909
3. the reference vessel diameter is between 2.75mm and 3.5mm
Beskrivning

Reference Vessel Diameter Size

Datatyp

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% (visual estimate) and <100% and a timi flow >1.
Beskrivning

Lesion Percent Diameter Stenosis Measurement | TIMI Flow Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3897965
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C4263591
5. study lesion has been successfully pre-dilated
Beskrivning

Lesion Dilatation Successful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1322279
UMLS CUI [1,3]
C1272703
6. patients enrolled for treatment may demonstrate multiple lesions in target vessel. however lesions must be covered completely by one study stent.
Beskrivning

Lesion multiple Target vessel | Placement of stent Single

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0449618
UMLS CUI [2,1]
C0522776
UMLS CUI [2,2]
C0205171
7. patient must have no more than two lesions requiring treatments. 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.
Beskrivning

Lesion Quantity Requirement Therapeutic procedure | Lesion Vessel Distribution Different

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C0037775
UMLS CUI [2,4]
C1705242
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 a taxus paclitaxel eluting stent or a bare metal stainless steel stent.
Beskrivning

Lesion Treated Successful | Paclitaxel drug-eluting stent | Bare metal stent Stainless Steel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C1272703
UMLS CUI [2]
C2199092
UMLS CUI [3,1]
C2825200
UMLS CUI [3,2]
C0038126
general exclusion criteria:
Beskrivning

Exclusion Criteria General

Datatyp

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
Beskrivning

Life Expectancy Due to Other medical condition

Datatyp

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
Beskrivning

Paclitaxel allergy | Hypersensitivity Compound Similar

Datatyp

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C2348205
3. patient exhibits cardiogenic shock (systolic pressure <80mmhg and pcwp >20mmhg or cardiac index <1.8 liters/minute/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80mmhg) for any time within 24 hours prior to index procedure
Beskrivning

Shock, Cardiogenic | Systolic Pressure | Pulmonary Capillary Wedge Pressure | Cardiac index | Intra-aortic balloon pump | Inotropic agent Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0086879
UMLS CUI [4]
C0428776
UMLS CUI [5]
C0702122
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 177 umol/l)
Beskrivning

Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum

Datatyp

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
Beskrivning

Cardiac Surgery procedure Planned

Datatyp

boolean

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

Myocardial Infarction | Elevated creatine kinase | Creatine kinase MB increased | Troponin increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0151576
UMLS CUI [3]
C0861005
UMLS CUI [4]
C1141948
7. patient exhibits acute st segment elevation mi within 72 hours prior to the index procedure
Beskrivning

ST segment elevation myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1536220
8. cva including stroke or tia within previous 3 months
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

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

Leukopenia

Datatyp

boolean

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

Thrombocytopenia | Thrombocytosis

Datatyp

boolean

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

Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine

Datatyp

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 taking warfarin or possibility of treatment with warfarin during the following 6 months post index procedure
Beskrivning

Warfarin | Warfarin Possibly

Datatyp

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
Beskrivning

Paclitaxel | Chemotherapeutic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0003392
14. anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
Beskrivning

Paclitaxel | Rapamycin Oral

Datatyp

boolean

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

Drug-Eluting Stent Implantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0021107
16. previous or planned treatment with intravascular brachytherapy in target vessel
Beskrivning

Intravascular brachytherapy Target vessel | Intravascular brachytherapy Planned Target vessel

Datatyp

boolean

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

Hypersensitivity Stainless Steel

Datatyp

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
Beskrivning

Intention Reproduction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0035150
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 9 months post index procedure
Beskrivning

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
angiographic exclusion criteria
Beskrivning

Exclusion Criteria Angiography

Datatyp

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
Beskrivning

Thrombus Probable Vessel Involved | Thrombus Vessel Involved | Angiography | IVUS

Datatyp

boolean

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

Lesion Occluded Total | TIMI Flow Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1947917
UMLS CUI [1,3]
C0439810
UMLS CUI [2,1]
C3272266
UMLS CUI [2,2]
C4263591
3. study lesion or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
Beskrivning

Lesion Calcified Moderate | Lesion Calcified Severe | Vessel Calcified Moderate | Vessel Calcified Severe

Datatyp

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

Lesion Location Ostium | Lesion Distance Vessel origin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0444567
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0012751
UMLS CUI [2,3]
C1301415
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
Beskrivning

Lesion Involving Tortuous coronary artery | Lesion Location Vessel Tortuosity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1272586
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C0333076
6. study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
Beskrivning

Lesion Involving Bifurcation | Branch Vessel Percent Diameter Stenosis Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C3146289
UMLS CUI [2,1]
C1253959
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C3897965
7. left main coronary artery disease (stenosis >50%) whether protected or unprotected
Beskrivning

Left main coronary artery disease | Stenosis Percent

Datatyp

boolean

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

Target Lesion Length

Datatyp

boolean

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

Target vessel Diameter Size

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
10. target vessel diameter <2.75 mm based on visual estimate by operator
Beskrivning

Target vessel Diameter Size

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
11. pre-treatment of the target lesion (excluding predilation) with another interventional device
Beskrivning

Pretreatment Target Lesion Using Investigational Medical Device | Exception Dilatation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C2346570
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1322279
Tillbaka till toppen

Similar models

Eligibility Coronary Artery Disease NCT00754975

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
1. patient is ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease | Patient eligible Percutaneous Coronary Intervention
Item
2. patient with coronary artery disease, eligible for percutaneous coronary intervention (pci)
boolean
C1956346 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
3. patient demonstrates a lvef of ≥ 25%
boolean
C0428772 (UMLS CUI [1])
Protocol Compliance | Protocol Compliance Legal Guardian | Informed Consent | 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])
C0525058 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
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 | Lesion de novo Coronary artery Native
Item
1. target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
boolean
C2986546 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0205042 (UMLS CUI [2,3])
C0302891 (UMLS CUI [2,4])
Stent Quantity Maximum Target Lesion | Lesion Length Maximum
Item
2. the target lesion can be treated with a maximum of one stent, with adequate coverage onto the healthy tissue, as specified in visual estimate guidelines. maximum lesion length is 20mm.
boolean
C0038257 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C2986546 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
Reference Vessel Diameter Size
Item
3. the reference vessel diameter is between 2.75mm and 3.5mm
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,4])
Lesion Percent Diameter Stenosis Measurement | TIMI Flow Grade
Item
4. study lesion diameter stenosis is ≥70% (visual estimate) and <100% and a timi flow >1.
boolean
C0221198 (UMLS CUI [1,1])
C3897965 (UMLS CUI [1,2])
C3272266 (UMLS CUI [2,1])
C4263591 (UMLS CUI [2,2])
Lesion Dilatation Successful
Item
5. study lesion has been successfully pre-dilated
boolean
C0221198 (UMLS CUI [1,1])
C1322279 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
Lesion multiple Target vessel | Placement of stent Single
Item
6. patients enrolled for treatment may demonstrate multiple lesions in target vessel. however lesions must be covered completely by one study stent.
boolean
C0221198 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
C0522776 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Lesion Quantity Requirement Therapeutic procedure | Lesion Vessel Distribution Different
Item
7. patient must have no more than two lesions requiring treatments. 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])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C0037775 (UMLS CUI [2,3])
C1705242 (UMLS CUI [2,4])
Lesion Treated Successful | Paclitaxel drug-eluting stent | Bare metal stent Stainless Steel
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 a taxus paclitaxel eluting stent or a bare metal stainless steel stent.
boolean
C0221198 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
C2199092 (UMLS CUI [2])
C2825200 (UMLS CUI [3,1])
C0038126 (UMLS CUI [3,2])
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 Compound Similar
Item
2. patient has a history of hypersensitivity to paclitaxel or structurally related compounds
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
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 <80mmhg and pcwp >20mmhg or cardiac index <1.8 liters/minute/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure >80mmhg) 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])
C0702122 (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 177 umol/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 | Creatine kinase MB increased | Troponin increased
Item
6. patient demonstrates evidence of myocardial infarction (elevated ck, ckmb or troponin) within 72 hours prior to the 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])
C0861005 (UMLS CUI [3])
C1141948 (UMLS CUI [4])
ST segment elevation myocardial infarction
Item
7. patient exhibits acute st segment elevation mi within 72 hours prior to the index procedure
boolean
C1536220 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
8. cva including stroke or tia within previous 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 Possibly
Item
12. patient is currently taking 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 Agents
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])
C0003392 (UMLS CUI [2])
Paclitaxel | Rapamycin Oral
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])
C0072980 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Drug-Eluting Stent Implantation
Item
15. patient has received a drug eluting stent within 12 months prior to planned index procedure
boolean
C1322815 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
Intravascular brachytherapy Target vessel | Intravascular brachytherapy Planned Target vessel
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])
C1301732 (UMLS CUI [2,2])
C0449618 (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])
Intention Reproduction
Item
18. male or female with known intention to procreate within 3 months after the index procedure
boolean
C1283828 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
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 9 months post index procedure
boolean
C0240802 (UMLS CUI [1])
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 Probable Vessel Involved | Thrombus Vessel Involved | Angiography | IVUS
Item
1. evidence of probable or definite thrombus of the study vessel, based on angiography or ivus
boolean
C0087086 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0087086 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0002978 (UMLS CUI [3])
C0206520 (UMLS CUI [4])
Lesion Occluded Total | TIMI Flow Grade
Item
2. study lesion is totally occluded (timi flow <= 1)either at baseline or before predilatation
boolean
C0221198 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C3272266 (UMLS CUI [2,1])
C4263591 (UMLS CUI [2,2])
Lesion Calcified Moderate | Lesion Calcified Severe | Vessel Calcified Moderate | Vessel Calcified Severe
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])
C0175895 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0005847 (UMLS CUI [4,1])
C0175895 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Lesion Location Ostium | Lesion Distance Vessel origin
Item
4. study lesion is ostial in location (within 3.0 mm of vessel origin)
boolean
C0221198 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0444567 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0012751 (UMLS CUI [2,2])
C1301415 (UMLS CUI [2,3])
Lesion Involving Tortuous coronary artery | Lesion Location Vessel Tortuosity
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])
C1314939 (UMLS CUI [1,2])
C1272586 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C0333076 (UMLS CUI [2,4])
Lesion Involving Bifurcation | Branch Vessel Percent Diameter Stenosis Measurement
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])
C3146289 (UMLS CUI [1,3])
C1253959 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C3897965 (UMLS CUI [2,3])
Left main coronary artery disease | Stenosis Percent
Item
7. left main coronary artery disease (stenosis >50%) whether protected or unprotected
boolean
C1299433 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Target Lesion Length
Item
8. target lesion length >20mm based on visual estimate by operator
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Target vessel Diameter Size
Item
9. target vessel diameter >3.5mm based on visual estimate by operator
boolean
C0449618 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Target vessel Diameter Size
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])
C0456389 (UMLS CUI [1,3])
Pretreatment Target Lesion Using Investigational Medical Device | Exception Dilatation
Item
11. pre-treatment of the target lesion (excluding predilation) with another interventional device
boolean
C3539076 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C2346570 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1322279 (UMLS CUI [2,2])
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