ID

28511

Description

The Optical Coherence Tomography Drug Eluting Stent Investigation; ODM derived from: https://clinicaltrials.gov/show/NCT00776204

Lien

https://clinicaltrials.gov/show/NCT00776204

Mots-clés

Versions (1)
  1. 20/01/2018 20/01/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 janvier 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00776204

Anglais

Eligibility Coronary Artery Disease NCT00776204

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria
Description

Inclusion criteria General

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. patient is ≥ 18 years of age
Description

Age

Type de données

boolean

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

Patient eligible Percutaneous Coronary Intervention

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C1532338
3. patient demonstrates a left ventricular ejection fraction (lvef) of ≥ 25%
Description

Left ventricular ejection fraction

Type de données

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.
Description

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

Type de données

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
Description

Inclusion criteria Angiography

Type de données

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) ≤ 25 mm that can be treated with a single jactax, jactax ld or taxus stent
Description

Target Lesion Identification | Lesion de novo Coronary artery Native | Lesion size | Therapeutic procedure Stent Single

Type de données

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
UMLS CUI [3]
C0449453
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0038257
UMLS CUI [4,3]
C0205171
2. a second lesion in a second vessel may be treated with one (1) taxus™ libertè™ des or a bare metal stent.
Description

Lesion second Vessel second | Therapeutic procedure Drug-Eluting Stent Single | Therapeutic procedure Bare metal stent Single

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205436
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0205436
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1322815
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2825200
UMLS CUI [3,3]
C0205171
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria
Description

Exclusion Criteria General

Type de données

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
Description

Life Expectancy Due to Other medical condition

Type de données

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
Description

Paclitaxel allergy | Hypersensitivity Compound Similar

Type de données

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 < 80mm hg and pcwp > 20mm hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm hg) for any time within 24 hours prior to index procedure
Description

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

Type de données

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 or177 µmol/l)
Description

Renal dysfunction | Renal dysfunction chronic | Creatinine measurement, serum

Type de données

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 ≤ 6 months post-index procedure
Description

Cardiac Surgery procedure Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
6. patient demonstrates evidence of a acute myocardial infarction (eg. stemi or enzyme elevation ck > 2x local laboratory's uln unless ck-mb is < 2x uln) 7) cerebrovascular accident (cva) including stroke or tia within previous 3 months
Description

Myocardial Infarction | STEMI | Elevated creatine kinase | Creatine kinase MB measurement | Cerebrovascular accident | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1536220
UMLS CUI [3]
C0151576
UMLS CUI [4]
C0523584
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
7. patient demonstrates evidence of leukopenia (leukocyte count < 3.5 x 109/liter)
Description

Leukopenia | White Blood Cell Count procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0023508
8. patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
Description

Thrombocytopenia | Platelet Count measurement | Thrombocytosis

Type de données

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0836924
9. patient is contraindicated to asa (successful prior desensitization to asa is not an exclusion), clopidogrel, or ticlopidine
Description

Medical contraindication Aspirin | Exception Desensitization Successful Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0178702
UMLS CUI [2,3]
C1272703
UMLS CUI [2,4]
C0004057
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0040207
10. patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
Description

Warfarin | Warfarin Possibly

Type de données

boolean

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

Paclitaxel | Chemotherapeutic Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0144576
UMLS CUI [2]
C0003392
12. anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
Description

Paclitaxel | Rapamycin Oral

Type de données

boolean

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

Drug-Eluting Stent Implantation

Type de données

boolean

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

Intravascular brachytherapy Target vessel | Intravascular brachytherapy Planned Target vessel

Type de données

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
15. known allergy to stainless steel
Description

Hypersensitivity Stainless Steel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038126
16. female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
Description

Intention Reproduction | Relationship Exposure to Paclitaxel

Type de données

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0035150
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0144576
17. 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
Description

Pregnancy test positive | Breast Feeding | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
18. patient that in the opinion of the investigator is not clinically appropriate for oct evaluation.
Description

Patient Inappropriate OCT Evaluation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0920367
UMLS CUI [1,4]
C1261322
angiographic exclusion criteria
Description

Exclusion Criteria Angiography

Type de données

boolean

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

Thrombus Vessel Involved | Angiography | IVUS

Type de données

boolean

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

Lesion Occluded Total | TIMI Flow Grade

Type de données

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
Description

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

Type de données

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)
Description

Lesion Location Ostium | Lesion Distance Vessel origin

Type de données

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
Description

Lesion Involving Tortuous coronary artery | Lesion Location Vessel Tortuosity

Type de données

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
Description

Lesion Involving Bifurcation | Branch Vessel Percent Diameter Stenosis Measurement

Type de données

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
Description

Left main coronary artery disease | Stenosis Percent

Type de données

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
8. target lesion length > 25 mm, based on visual estimate by operator
Description

Target Lesion Length

Type de données

boolean

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

Target vessel Diameter Size

Type de données

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
Description

Target vessel Diameter Size

Type de données

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.
Description

Pretreatment Target Lesion Using Investigational Medical Device | Exception Dilatation

Type de données

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
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Similar models

Eligibility Coronary Artery Disease NCT00776204

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
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 a left ventricular ejection fraction (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 | Lesion size | Therapeutic procedure Stent Single
Item
1. target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated) ≤ 25 mm that can be treated with a single jactax, jactax ld or taxus stent
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])
C0449453 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0038257 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Lesion second Vessel second | Therapeutic procedure Drug-Eluting Stent Single | Therapeutic procedure Bare metal stent Single
Item
2. a second lesion in a second vessel may be treated with one (1) taxus™ libertè™ des or a bare metal stent.
boolean
C0221198 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0205436 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C1322815 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C2825200 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
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 < 80mm hg and pcwp > 20mm hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm hg) 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 or177 µmol/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 ≤ 6 months post-index procedure
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Myocardial Infarction | STEMI | Elevated creatine kinase | Creatine kinase MB measurement | Cerebrovascular accident | Transient Ischemic Attack
Item
6. patient demonstrates evidence of a acute myocardial infarction (eg. stemi or enzyme elevation ck > 2x local laboratory's uln unless ck-mb is < 2x uln) 7) cerebrovascular accident (cva) including stroke or tia within previous 3 months
boolean
C0027051 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
C0523584 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Leukopenia | White Blood Cell Count procedure
Item
7. patient demonstrates evidence of leukopenia (leukocyte count < 3.5 x 109/liter)
boolean
C0023530 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement | Thrombocytosis
Item
8. patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0836924 (UMLS CUI [3])
Medical contraindication Aspirin | Exception Desensitization Successful Aspirin | Medical contraindication Clopidogrel | Medical contraindication Ticlopidine
Item
9. patient is contraindicated to asa (successful prior desensitization to asa is not an exclusion), clopidogrel, or ticlopidine
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0178702 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0004057 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0040207 (UMLS CUI [4,2])
Warfarin | Warfarin Possibly
Item
10. 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 Agents
Item
11. 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
12. anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-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
13. 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
14. 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
15. known allergy to stainless steel
boolean
C0020517 (UMLS CUI [1,1])
C0038126 (UMLS CUI [1,2])
Intention Reproduction | Relationship Exposure to Paclitaxel
Item
16. female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
boolean
C1283828 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0144576 (UMLS CUI [2,3])
Pregnancy test positive | Breast Feeding | Pregnancy, Planned
Item
17. 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])
Patient Inappropriate OCT Evaluation
Item
18. patient that in the opinion of the investigator is not clinically appropriate for oct evaluation.
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
Exclusion Criteria Angiography
Item
angiographic exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Thrombus Vessel Involved | Angiography | IVUS
Item
1. evidence of 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])
C0002978 (UMLS CUI [2])
C0206520 (UMLS CUI [3])
Lesion Occluded Total | TIMI Flow Grade
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 [2,1])
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 > 25 mm, 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 > 3.5 mm, 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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