ID

16911

Description

TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00371709

Lien

https://clinicaltrials.gov/show/NCT00371709

Mots-clés

Versions (1)
  1. 13/08/2016 13/08/2016 -
Téléchargé le

13 août 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00371709

Anglais

Eligibility Coronary Artery Disease NCT00371709

1 Formulaires  
Criteria
Description

Criteria

1. patient is ≥18 years old.
Description

Age

Type de données

boolean

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

Percutaneous Coronary Intervention

Type de données

boolean

Alias
UMLS CUI [1]
C1532338
3. documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
Description

Stable angina | Angina, Unstable | Ischemia | Silent myocardial ischemia

Type de données

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0022116
UMLS CUI [4]
C0340291
4. left ventricular ejection fraction (lvef) of >/=25%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
5. acceptable candidate for coronary artery bypass grafting (cabg)
Description

Indication Coronary Artery Bypass Surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0010055
6. patient or legal guardian understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
Description

Informed Consent | Informed Consent Legal Guardian

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
7. willing to comply with all specified follow-up evaluations
Description

Follow-up Evaluation Compliance behavior

Type de données

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1321605
angiographic inclusion criteria:
Description

Inclusion criteria angiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
1. only one lesion (target lesion) may be treated with the study stent. however, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or taxus express stent.
Description

Therapeutic procedure Target Lesion Stent | Therapeutic procedure Lesion Bare metal stent | Insertion of drug-coated stent(s), i.e. heparin coated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0038257
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C2825200
UMLS CUI [3]
C1135499
2. target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments)but must be completely covered by one study stent.
Description

Therapeutic procedure Target Lesion | Therapeutic procedure Multiple lesions Covered Stent One

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2986546
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0577305
UMLS CUI [2,3]
C0439844
UMLS CUI [2,4]
C0038257
UMLS CUI [2,5]
C0205447
3. target lesion located within a single native coronary artery
Description

Target Lesion Location Within Coronary artery Native Single

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0332285
UMLS CUI [1,4]
C0205042
UMLS CUI [1,5]
C0302891
UMLS CUI [1,6]
C0205171
4. cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
Description

Target Lesion Cumulative Length | Visual estimation

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1511559
UMLS CUI [1,3]
C1444754
UMLS CUI [2]
C0444684
5. rvd of ≥2.5 mm to ≤4.0 mm (visual estimate)
Description

Reference Vessel Diameter | Visual estimation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
UMLS CUI [2]
C0444684
6. target lesion diameter stenosis ≥50% (visual estimate)
Description

Target Lesion Diameter Stenosis Percentage | Visual estimation

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0678234
UMLS CUI [1,4]
C0439165
UMLS CUI [2]
C0444684
7. target lesion is de novo (i.e., a coronary lesion not previously treated)
Description

Target Lesion Coronary de novo

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1522318
UMLS CUI [1,3]
C1515568
general exclusion criteria:
Description

Exclusion Criteria General

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
1. known hypersensitivity to paclitaxel
Description

Hypersensitivity Paclitaxel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0144576
2. any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
Description

Therapeutic procedure Drug-Coated Stent Coronary Against Restenosis | Therapeutic procedure Drug-Eluting Coronary Stent Against Restenosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1445093
UMLS CUI [1,3]
C1522318
UMLS CUI [1,4]
C0521124
UMLS CUI [1,5]
C0333186
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1262327
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0333186
3. previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
Description

Therapeutic procedure Target vessel Stent Investigational | Therapeutic procedure Target vessel Stent commercial

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0449618
UMLS CUI [1,3]
C0038257
UMLS CUI [1,4]
C1517586
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0449618
UMLS CUI [2,3]
C0038257
UMLS CUI [2,4]
C0680536
4. previous or planned treatment with intravascular brachytherapy in the target vessel
Description

intravascular brachytherapy Target vessel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0994608
UMLS CUI [1,2]
C0449618
5. planned cabg ≤9-months post-index procedure
Description

Coronary Artery Bypass Surgery Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C1301732
6. mi within 72 hours prior to the index procedure and or creatine kinase(ck) >2x the local laboratory's uln unless ck-mb is <2x uln.
Description

Myocardial Infarction | Creatine kinase measurement | Creatine kinase MB measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0201973
UMLS CUI [3]
C0523584
7. cerebrovascular accident (cva) within the past 6 months
Description

Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
8. cardiogenic shock
Description

Shock, Cardiogenic

Type de données

boolean

Alias
UMLS CUI [1]
C0036980
9. acute or chronic renal dysfunction
Description

Renal dysfunction | Renal dysfunction chronic

Type de données

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205191
10. contraindication to asa, or to both clopidogrel and ticlopidine
Description

Medical contraindication 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]
C1301624
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0040207
11. leukopenia
Description

Leukopenia

Type de données

boolean

Alias
UMLS CUI [1]
C0023530
12. thrombocytopenia or thrombocytosis
Description

Thrombocytopenia Thrombocytosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0836924
13. active peptic ulcer or active gastrointestinal (gi) bleeding
Description

Peptic Ulcer | Gastrointestinal Hemorrhage

Type de données

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
14. known allergy to stainless steel
Description

Hypersensitivity Stainless Steel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038126
15. any prior true anaphylactic reaction to contrast agents
Description

anaphylaxis Contrast Media

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0009924
16. patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
Description

Paclitaxel | Chemotherapeutic agent

Type de données

boolean

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

Paclitaxel Anticipated | Sirolimus Oral Anticipated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0072980
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C3840775
18. male or female with known intention to procreate within 3 months after the index procedure
Description

Gender Reproduction intent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0035150
UMLS CUI [1,3]
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 study.
Description

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
20. life expectancy of less than 24-months due to other medical condition
Description

Life Expectancy Duration Due to Other medical condition

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C3843040
21. co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
Description

Comorbidity Study Subject Participation Status Limited | Comorbidity Protocol Compliance Limited | Comorbidity Interferes with research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
22. currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
angiographic exclusion criteria:
Description

Exclusion Criteria angiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0002978
1. left main coronary artery disease (stenosis >50%) whether protected or unprotected
Description

Left main coronary artery disease | Stenosis Percentage

Type de données

boolean

Alias
UMLS CUI [1]
C1299433
UMLS CUI [2,1]
C0678234
UMLS CUI [2,2]
C0439165
2. target lesion is ostial in location (within 3.0 mm of vessel origin)
Description

Target Lesion Location Ostium | Target Lesion Distance Vessel origin

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0444567
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0012751
UMLS CUI [2,3]
C1301415
3. target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate.
Description

Target Lesion Calcified Moderate | Target Lesion Calcified Severe | Target vessel Proximal Calcified Moderate | Target vessel Proxima Calcified Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0175895
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0449618
UMLS CUI [3,2]
C0205107
UMLS CUI [3,3]
C0175895
UMLS CUI [3,4]
C0205081
UMLS CUI [4,1]
C0449618
UMLS CUI [4,2]
C0205107
UMLS CUI [4,3]
C0175895
UMLS CUI [4,4]
C0205082
4. target lesion and/or target vessel proximal to the target lesion is tortuous.
Description

Target Lesion Tortuous | Target vessel Proximal Tortuous

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C4068863
UMLS CUI [2,1]
C0449618
UMLS CUI [2,2]
C0205107
UMLS CUI [2,3]
C4068863
5. target lesion is located within or distal to a >60 degree bend in the vessel
Description

Target Lesion Location Related Vessel

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0005847
6. target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.
Description

Target Lesion Involvement with Coronary Vessel Bifurcation Lesion Diameter

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C3640041
UMLS CUI [1,4]
C1301886
7. target lesion is totally occluded (timi flow </= 1), either at baseline or predilation
Description

Target Lesion Occluded Total | TIMI grade 0: no perfusion | TIMI grade 1: penetration without perfusion

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1947917
UMLS CUI [1,3]
C0439810
UMLS CUI [2]
C1299341
UMLS CUI [3]
C1299340
8. angiographic presence of probable or definite thrombus
Description

Definite thrombus | Thrombus Probable | angiography

Type de données

boolean

Alias
UMLS CUI [1]
C1298826
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C0033204
UMLS CUI [3]
C0002978
9. pre-treatment of the target vessel is not allowed with any device
Description

Target vessel Pretreatment Medical Device Illicit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C0332266
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Similar models

Eligibility Coronary Artery Disease NCT00371709

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Age
Item
1. patient is ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
Percutaneous Coronary Intervention
Item
2. eligible for percutaneous coronary intervention (pci)
boolean
C1532338 (UMLS CUI [1])
Stable angina | Angina, Unstable | Ischemia | Silent myocardial ischemia
Item
3. documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0022116 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
Left ventricular ejection fraction
Item
4. left ventricular ejection fraction (lvef) of >/=25%
boolean
C0428772 (UMLS CUI [1])
Indication Coronary Artery Bypass Surgery
Item
5. acceptable candidate for coronary artery bypass grafting (cabg)
boolean
C3146298 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Informed Consent | Informed Consent Legal Guardian
Item
6. patient or legal guardian understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Follow-up Evaluation Compliance behavior
Item
7. willing to comply with all specified follow-up evaluations
boolean
C3274571 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Inclusion criteria angiography
Item
angiographic inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Therapeutic procedure Target Lesion Stent | Therapeutic procedure Lesion Bare metal stent | Insertion of drug-coated stent(s), i.e. heparin coated
Item
1. only one lesion (target lesion) may be treated with the study stent. however, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or taxus express stent.
boolean
C0087111 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C2825200 (UMLS CUI [2,3])
C1135499 (UMLS CUI [3])
Therapeutic procedure Target Lesion | Therapeutic procedure Multiple lesions Covered Stent One
Item
2. target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments)but must be completely covered by one study stent.
boolean
C0087111 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0577305 (UMLS CUI [2,2])
C0439844 (UMLS CUI [2,3])
C0038257 (UMLS CUI [2,4])
C0205447 (UMLS CUI [2,5])
Target Lesion Location Within Coronary artery Native Single
Item
3. target lesion located within a single native coronary artery
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0332285 (UMLS CUI [1,3])
C0205042 (UMLS CUI [1,4])
C0302891 (UMLS CUI [1,5])
C0205171 (UMLS CUI [1,6])
Target Lesion Cumulative Length | Visual estimation
Item
4. cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
boolean
C2986546 (UMLS CUI [1,1])
C1511559 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C0444684 (UMLS CUI [2])
Reference Vessel Diameter | Visual estimation
Item
5. rvd of ≥2.5 mm to ≤4.0 mm (visual estimate)
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
C0444684 (UMLS CUI [2])
Target Lesion Diameter Stenosis Percentage | Visual estimation
Item
6. target lesion diameter stenosis ≥50% (visual estimate)
boolean
C2986546 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0678234 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0444684 (UMLS CUI [2])
Target Lesion Coronary de novo
Item
7. target lesion is de novo (i.e., a coronary lesion not previously treated)
boolean
C2986546 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
Exclusion Criteria General
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Hypersensitivity Paclitaxel
Item
1. known hypersensitivity to paclitaxel
boolean
C0020517 (UMLS CUI [1,1])
C0144576 (UMLS CUI [1,2])
Therapeutic procedure Drug-Coated Stent Coronary Against Restenosis | Therapeutic procedure Drug-Eluting Coronary Stent Against Restenosis
Item
2. any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
boolean
C0087111 (UMLS CUI [1,1])
C1445093 (UMLS CUI [1,2])
C1522318 (UMLS CUI [1,3])
C0521124 (UMLS CUI [1,4])
C0333186 (UMLS CUI [1,5])
C0087111 (UMLS CUI [2,1])
C1262327 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0333186 (UMLS CUI [2,4])
Therapeutic procedure Target vessel Stent Investigational | Therapeutic procedure Target vessel Stent commercial
Item
3. previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
boolean
C0087111 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1517586 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0449618 (UMLS CUI [2,2])
C0038257 (UMLS CUI [2,3])
C0680536 (UMLS CUI [2,4])
intravascular brachytherapy Target vessel
Item
4. previous or planned treatment with intravascular brachytherapy in the target vessel
boolean
C0994608 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery Planned
Item
5. planned cabg ≤9-months post-index procedure
boolean
C0010055 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Myocardial Infarction | Creatine kinase measurement | Creatine kinase MB measurement
Item
6. mi within 72 hours prior to the index procedure and or creatine kinase(ck) >2x the local laboratory's uln unless ck-mb is <2x uln.
boolean
C0027051 (UMLS CUI [1])
C0201973 (UMLS CUI [2])
C0523584 (UMLS CUI [3])
Cerebrovascular accident
Item
7. cerebrovascular accident (cva) within the past 6 months
boolean
C0038454 (UMLS CUI [1])
Shock, Cardiogenic
Item
8. cardiogenic shock
boolean
C0036980 (UMLS CUI [1])
Renal dysfunction | Renal dysfunction chronic
Item
9. acute or chronic renal dysfunction
boolean
C3279454 (UMLS CUI [1])
C3279454 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Medical contraindication Aspirin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine
Item
10. contraindication to asa, or to both clopidogrel and 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])
Leukopenia
Item
11. leukopenia
boolean
C0023530 (UMLS CUI [1])
Thrombocytopenia Thrombocytosis
Item
12. thrombocytopenia or thrombocytosis
boolean
C0040034 (UMLS CUI [1,1])
C0836924 (UMLS CUI [1,2])
Peptic Ulcer | Gastrointestinal Hemorrhage
Item
13. active peptic ulcer or active gastrointestinal (gi) bleeding
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Hypersensitivity Stainless Steel
Item
14. known allergy to stainless steel
boolean
C0020517 (UMLS CUI [1,1])
C0038126 (UMLS CUI [1,2])
anaphylaxis Contrast Media
Item
15. any prior true anaphylactic reaction to contrast agents
boolean
C0002792 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
Paclitaxel | Chemotherapeutic agent
Item
16. patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
boolean
C0144576 (UMLS CUI [1])
C0729502 (UMLS CUI [2])
Paclitaxel Anticipated | Sirolimus Oral Anticipated
Item
17. anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
boolean
C0144576 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0072980 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Gender Reproduction intent
Item
18. male or female with known intention to procreate within 3 months after the index procedure
boolean
C0079399 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
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 study.
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Life Expectancy Duration Due to Other medical condition
Item
20. life expectancy of less than 24-months due to other medical condition
boolean
C0023671 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C3843040 (UMLS CUI [1,4])
Comorbidity Study Subject Participation Status Limited | Comorbidity Protocol Compliance Limited | Comorbidity Interferes with research results
Item
21. co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
22. currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Exclusion Criteria angiography
Item
angiographic exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Left main coronary artery disease | Stenosis Percentage
Item
1. left main coronary artery disease (stenosis >50%) whether protected or unprotected
boolean
C1299433 (UMLS CUI [1])
C0678234 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Target Lesion Location Ostium | Target Lesion Distance Vessel origin
Item
2. target lesion is ostial in location (within 3.0 mm of vessel origin)
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0444567 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0012751 (UMLS CUI [2,2])
C1301415 (UMLS CUI [2,3])
Target Lesion Calcified Moderate | Target Lesion Calcified Severe | Target vessel Proximal Calcified Moderate | Target vessel Proxima Calcified Severe
Item
3. target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate.
boolean
C2986546 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C0175895 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0449618 (UMLS CUI [3,1])
C0205107 (UMLS CUI [3,2])
C0175895 (UMLS CUI [3,3])
C0205081 (UMLS CUI [3,4])
C0449618 (UMLS CUI [4,1])
C0205107 (UMLS CUI [4,2])
C0175895 (UMLS CUI [4,3])
C0205082 (UMLS CUI [4,4])
Target Lesion Tortuous | Target vessel Proximal Tortuous
Item
4. target lesion and/or target vessel proximal to the target lesion is tortuous.
boolean
C2986546 (UMLS CUI [1,1])
C4068863 (UMLS CUI [1,2])
C0449618 (UMLS CUI [2,1])
C0205107 (UMLS CUI [2,2])
C4068863 (UMLS CUI [2,3])
Target Lesion Location Related Vessel
Item
5. target lesion is located within or distal to a >60 degree bend in the vessel
boolean
C2986546 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0005847 (UMLS CUI [1,4])
Target Lesion Involvement with Coronary Vessel Bifurcation Lesion Diameter
Item
6. target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.
boolean
C2986546 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C3640041 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
Target Lesion Occluded Total | TIMI grade 0: no perfusion | TIMI grade 1: penetration without perfusion
Item
7. target lesion is totally occluded (timi flow </= 1), either at baseline or predilation
boolean
C2986546 (UMLS CUI [1,1])
C1947917 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C1299341 (UMLS CUI [2])
C1299340 (UMLS CUI [3])
Definite thrombus | Thrombus Probable | angiography
Item
8. angiographic presence of probable or definite thrombus
boolean
C1298826 (UMLS CUI [1])
C0087086 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0002978 (UMLS CUI [3])
Target vessel Pretreatment Medical Device Illicit
Item
9. pre-treatment of the target vessel is not allowed with any device
boolean
C0449618 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0332266 (UMLS CUI [1,4])
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