ID

28491

Beschrijving

Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing; ODM derived from: https://clinicaltrials.gov/show/NCT00698607

Link

https://clinicaltrials.gov/show/NCT00698607

Trefwoorden

Versies (1)
  1. 18-01-18 18-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00698607

Engels

Eligibility Coronary Artery Disease NCT00698607

1 Formulieren  
Criteria
Beschrijving

Criteria

1. subject must be at least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the xience v eecs and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
3. subject must have significant coronary artery stenosis (>50% by visual estimate)
Beschrijving

Coronary Stenosis Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C0439165
4. subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ecg) consistent with ischemia. in subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
Beschrijving

Myocardial Ischemia | Stable angina | Angina, Unstable | Infarction Recent | Silent myocardial ischemia | Test Functional Positive | Electrocardiographic changes Reversible Consistent with Ischemia | Coronary Stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0021308
UMLS CUI [4,2]
C0332185
UMLS CUI [5]
C0340291
UMLS CUI [6,1]
C0039593
UMLS CUI [6,2]
C0205245
UMLS CUI [6,3]
C1514241
UMLS CUI [7,1]
C0855329
UMLS CUI [7,2]
C0205343
UMLS CUI [7,3]
C0332290
UMLS CUI [7,4]
C0022116
UMLS CUI [8]
C0242231
5. subjects must be an acceptable candidate for coronary artery bypass graft (cabg) surgery.
Beschrijving

Subject Appropriate Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0010055
angiographically inclusion criteria
Beschrijving

Inclusion criteria Angiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
1. target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
Beschrijving

Target Lesion Coronary artery Native | Target Lesion Diameter Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0205042
UMLS CUI [1,3]
C0302891
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
2. target lesion(s) must be amenable for percutaneous coronary intervention
Beschrijving

Target Lesion Amenable Percutaneous Coronary Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1532338
general exclusion criteria:
Beschrijving

Exclusion Criteria General

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
1. the patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast media
Beschrijving

Heparin allergy | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Contrast media allergy | Medical contraindication Heparin | Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Sirolimus | Medical contraindication Everolimus | Medical contraindication Contrast Media

Datatype

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2]
C0004058
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0541315
UMLS CUI [6]
C0570562
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0019134
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0004057
UMLS CUI [9,1]
C1301624
UMLS CUI [9,2]
C0070166
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0072980
UMLS CUI [11,1]
C1301624
UMLS CUI [11,2]
C0541315
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C0009924
2. systemic (intravenous) sirolimus, everolimus use within 12 months.
Beschrijving

Sirolimus Intravenous Systemic | everolimus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0072980
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205373
UMLS CUI [2]
C0541315
3. female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
Beschrijving

Childbearing Potential | Exception Pregnancy test negative | Pregnancy Planned Possibly

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0332149
4. history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Beschrijving

Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Blood Transfusion Refused

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0272285
UMLS CUI [4,1]
C0005841
UMLS CUI [4,2]
C1705116
5. gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Beschrijving

Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0919591
UMLS CUI [3]
C0679637
6. current known current platelet count <100,000 cells/mm3 or hgb <10 g/dl.
Beschrijving

Platelet Count measurement | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0518015
7. an elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
Beschrijving

Elective Surgical Procedure Planned | Clopidogrel To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0070166
UMLS CUI [2,2]
C1272691
8. non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Beschrijving

Comorbidity Protocol Compliance Lacking | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C0023671
9. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Beschrijving

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2986535
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0205257
10. patients who have received any stent implantation in the target vessel prior to enrollment.
Beschrijving

Placement of stent Target vessel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522776
UMLS CUI [1,2]
C0449618
11. patients with lvef<25% or those with cardiogenic shock
Beschrijving

Left ventricular ejection fraction | Shock, Cardiogenic

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0036980
12. patients with myocardial infarction within 72 hours
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
13. creatinine level ≥ 3.0mg/dl or dependence on dialysis.
Beschrijving

Creatinine measurement, serum | Dependence on renal dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0524376
14. severe hepatic dysfunction (ast and alt: 3 times upper normal reference values).
Beschrijving

Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
angiographic exclusion criteria
Beschrijving

Exclusion Criteria Angiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0002978
1. patients with significant left main coronary artery stenosis
Beschrijving

left main coronary artery stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C2062905
2. patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
Beschrijving

Target Lesion In Stent restenosis | Drug-Eluting Stents | Bare metal stent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C3272317
UMLS CUI [2]
C1322815
UMLS CUI [3]
C2825200
3. target lesions with chronic total occlusion
Beschrijving

Target Lesion Chronic total occlusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1955779
4. true bifurcation lesions requiring two stents
Beschrijving

Bifurcation lesion Requirement Stent Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0038257
UMLS CUI [1,4]
C1265611
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Eligibility Coronary Artery Disease NCT00698607

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Age
Item
1. subject must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
2. subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the xience v eecs and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Coronary Stenosis Percentage
Item
3. subject must have significant coronary artery stenosis (>50% by visual estimate)
boolean
C0242231 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Myocardial Ischemia | Stable angina | Angina, Unstable | Infarction Recent | Silent myocardial ischemia | Test Functional Positive | Electrocardiographic changes Reversible Consistent with Ischemia | Coronary Stenosis
Item
4. subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ecg) consistent with ischemia. in subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0021308 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0340291 (UMLS CUI [5])
C0039593 (UMLS CUI [6,1])
C0205245 (UMLS CUI [6,2])
C1514241 (UMLS CUI [6,3])
C0855329 (UMLS CUI [7,1])
C0205343 (UMLS CUI [7,2])
C0332290 (UMLS CUI [7,3])
C0022116 (UMLS CUI [7,4])
C0242231 (UMLS CUI [8])
Subject Appropriate Coronary Artery Bypass Surgery
Item
5. subjects must be an acceptable candidate for coronary artery bypass graft (cabg) surgery.
boolean
C0681850 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
Inclusion criteria Angiography
Item
angiographically inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Target Lesion Coronary artery Native | Target Lesion Diameter Size
Item
1. target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
boolean
C2986546 (UMLS CUI [1,1])
C0205042 (UMLS CUI [1,2])
C0302891 (UMLS CUI [1,3])
C2986546 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
Target Lesion Amenable Percutaneous Coronary Intervention
Item
2. target lesion(s) must be amenable for percutaneous coronary intervention
boolean
C2986546 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
Exclusion Criteria General
Item
general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Heparin allergy | Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Contrast media allergy | Medical contraindication Heparin | Medical contraindication Aspirin | Medical contraindication Clopidogrel | Medical contraindication Sirolimus | Medical contraindication Everolimus | Medical contraindication Contrast Media
Item
1. the patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast media
boolean
C0571776 (UMLS CUI [1])
C0004058 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0541315 (UMLS CUI [5,2])
C0570562 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0019134 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C1301624 (UMLS CUI [9,1])
C0070166 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0072980 (UMLS CUI [10,2])
C1301624 (UMLS CUI [11,1])
C0541315 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C0009924 (UMLS CUI [12,2])
Sirolimus Intravenous Systemic | everolimus
Item
2. systemic (intravenous) sirolimus, everolimus use within 12 months.
boolean
C0072980 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0541315 (UMLS CUI [2])
Childbearing Potential | Exception Pregnancy test negative | Pregnancy Planned Possibly
Item
3. female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Blood Transfusion Refused
Item
4. history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0272285 (UMLS CUI [3])
C0005841 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery
Item
5. gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
boolean
C0017181 (UMLS CUI [1])
C0919591 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Platelet Count measurement | Hemoglobin measurement
Item
6. current known current platelet count <100,000 cells/mm3 or hgb <10 g/dl.
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Elective Surgical Procedure Planned | Clopidogrel To be stopped
Item
7. an elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Comorbidity Protocol Compliance Lacking | Life Expectancy
Item
8. non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
boolean
C0009488 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Follow-up Incomplete
Item
9. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
Placement of stent Target vessel
Item
10. patients who have received any stent implantation in the target vessel prior to enrollment.
boolean
C0522776 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Left ventricular ejection fraction | Shock, Cardiogenic
Item
11. patients with lvef<25% or those with cardiogenic shock
boolean
C0428772 (UMLS CUI [1])
C0036980 (UMLS CUI [2])
Myocardial Infarction
Item
12. patients with myocardial infarction within 72 hours
boolean
C0027051 (UMLS CUI [1])
Creatinine measurement, serum | Dependence on renal dialysis
Item
13. creatinine level ≥ 3.0mg/dl or dependence on dialysis.
boolean
C0201976 (UMLS CUI [1])
C0524376 (UMLS CUI [2])
Liver Dysfunction Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
14. severe hepatic dysfunction (ast and alt: 3 times upper normal reference values).
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (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 stenosis
Item
1. patients with significant left main coronary artery stenosis
boolean
C2062905 (UMLS CUI [1])
Target Lesion In Stent restenosis | Drug-Eluting Stents | Bare metal stent
Item
2. patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
boolean
C2986546 (UMLS CUI [1,1])
C3272317 (UMLS CUI [1,2])
C1322815 (UMLS CUI [2])
C2825200 (UMLS CUI [3])
Target Lesion Chronic total occlusion
Item
3. target lesions with chronic total occlusion
boolean
C2986546 (UMLS CUI [1,1])
C1955779 (UMLS CUI [1,2])
Bifurcation lesion Requirement Stent Quantity
Item
4. true bifurcation lesions requiring two stents
boolean
C1299363 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
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