ID

35560

Beschreibung

Comparison of Biomatrix and Orsiro Drug Eluting Stent; ODM derived from: https://clinicaltrials.gov/show/NCT02299011

Link

https://clinicaltrials.gov/show/NCT02299011

Stichworte

Versionen (1)
  1. 09.03.19 09.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02299011

Englisch

Eligibility Coronary Artery Disease NCT02299011

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. general inclusion criteria
Beschreibung

Inclusion criteria General

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
1. subject must be at least 18 years of age.
Beschreibung

Age

Datentyp

boolean

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

Comprehension Study Protocol | Stent Specified | Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0038257
UMLS CUI [2,2]
C0205369
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
3. subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
Beschreibung

Lesion Coronary artery Percentage | Bypass graft Venous | Bypass graft Arterial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205042
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0185098
UMLS CUI [2,2]
C0348013
UMLS CUI [3,1]
C0185098
UMLS CUI [3,2]
C0221464
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 diameter stenosis > 70%, evidence of myocardial ischemia does not have to be documented.
Beschreibung

Myocardial Ischemia | Stable angina | Angina, Unstable | Recent myocardial infarction | Silent myocardial ischemia | Heart Function Tests Positive | ECG changes Reversible Consistent with Ischemia | Percent Diameter Stenosis Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C1998297
UMLS CUI [5]
C0340291
UMLS CUI [6,1]
C0018803
UMLS CUI [6,2]
C1514241
UMLS CUI [7,1]
C0855329
UMLS CUI [7,2]
C0205343
UMLS CUI [7,3]
C0332290
UMLS CUI [7,4]
C0022116
UMLS CUI [8]
C3897965
2. angiographic inclusion criteria
Beschreibung

Inclusion criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0002978
1. target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.
Beschreibung

Target Lesion Location Coronary artery | Bypass graft Venous Diameter | Bypass graft Arterial Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205042
UMLS CUI [2,1]
C0185098
UMLS CUI [2,2]
C0348013
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0185098
UMLS CUI [3,2]
C0221464
UMLS CUI [3,3]
C1301886
2. target lesion(s) must be amenable for percutaneous coronary intervention.
Beschreibung

Target Lesion Amenable Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1532338
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, prasugrel, ticagrelor, biolimus, sirolimus, contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
Beschreibung

Heparin allergy | Medical contraindication Heparin | Aspirin allergy | Medical contraindication Aspirin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel | Hypersensitivity Cilostazol | Medical contraindication Cilostazol | Hypersensitivity Prasugrel | Medical contraindication Prasugrel | Hypersensitivity Ticagrelor | Medical contraindication Ticagrelor | Hypersensitivity Biolimus A9 | Medical contraindication Biolimus A9 | Hypersensitivity Sirolimus | Medical contraindication Sirolimus | Contrast media allergy | Medical contraindication Contrast Media

Datentyp

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3]
C0004058
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0004057
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0070166
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0070166
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0055729
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0055729
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C1620287
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C1620287
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C1999375
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C1999375
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C4310325
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C4310325
UMLS CUI [15,1]
C0020517
UMLS CUI [15,2]
C0072980
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C0072980
UMLS CUI [17]
C0570562
UMLS CUI [18,1]
C1301624
UMLS CUI [18,2]
C0009924
2. systemic (intravenous) biolimus or sirolimus use within 12 months.
Beschreibung

Biolimus A9 Intravenous Systemic | Sirolimus Intravenous Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4310325
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C0072980
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0205373
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.
Beschreibung

Childbearing Potential Planned Pregnancy Possible | Exception Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032992
UMLS CUI [1,3]
C0332149
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0427780
4. history of bleeding diathesis, known coagulopathy (including heparin- induced thrombocytopenia), abnormal hemogram (hb<10g/dl or plt count <100,000/μl) or will refuse blood transfusions
Beschreibung

Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Hemogram Abnormal | Hemoglobin measurement | Platelet Count measurement | Blood Transfusion Refused

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0272285
UMLS CUI [4,1]
C0200631
UMLS CUI [4,2]
C0205161
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0032181
UMLS CUI [7,1]
C0005841
UMLS CUI [7,2]
C1705116
5. patients with severe lv systolic dysfunction (lvef<25%) or cardiogenic shock
Beschreibung

Left ventricular systolic dysfunction | Left ventricular ejection fraction | Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C1277187
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0036980
6. gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.
Beschreibung

Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0919591
UMLS CUI [3]
C0679637
7. 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).
Beschreibung

Comorbidity | Exception Heart Diseases | Life Expectancy | Protocol Compliance Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0332268
8. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow- up period.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | End Point Primary Incomplete

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2349179
UMLS CUI [4,2]
C0205225
UMLS CUI [4,3]
C0205257
9. symptomatic heart failure
Beschreibung

Heart failure Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT02299011

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
1. general inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Age
Item
1. subject must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Stent Specified | Informed Consent | Informed Consent Patient Representative
Item
2. subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the biomatrix flex stents or orsiro stents, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0038257 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Lesion Coronary artery Percentage | Bypass graft Venous | Bypass graft Arterial
Item
3. subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
boolean
C0221198 (UMLS CUI [1,1])
C0205042 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0185098 (UMLS CUI [2,1])
C0348013 (UMLS CUI [2,2])
C0185098 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
Myocardial Ischemia | Stable angina | Angina, Unstable | Recent myocardial infarction | Silent myocardial ischemia | Heart Function Tests Positive | ECG changes Reversible Consistent with Ischemia | Percent Diameter Stenosis Measurement
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 diameter stenosis > 70%, evidence of myocardial ischemia does not have to be documented.
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C1998297 (UMLS CUI [4])
C0340291 (UMLS CUI [5])
C0018803 (UMLS CUI [6,1])
C1514241 (UMLS CUI [6,2])
C0855329 (UMLS CUI [7,1])
C0205343 (UMLS CUI [7,2])
C0332290 (UMLS CUI [7,3])
C0022116 (UMLS CUI [7,4])
C3897965 (UMLS CUI [8])
Inclusion criteria Angiography
Item
2. angiographic inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Target Lesion Location Coronary artery | Bypass graft Venous Diameter | Bypass graft Arterial Diameter
Item
1. target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0185098 (UMLS CUI [2,1])
C0348013 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0185098 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
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])
Item Group
C0680251 (UMLS CUI)
Heparin allergy | Medical contraindication Heparin | Aspirin allergy | Medical contraindication Aspirin | Hypersensitivity Clopidogrel | Medical contraindication Clopidogrel | Hypersensitivity Cilostazol | Medical contraindication Cilostazol | Hypersensitivity Prasugrel | Medical contraindication Prasugrel | Hypersensitivity Ticagrelor | Medical contraindication Ticagrelor | Hypersensitivity Biolimus A9 | Medical contraindication Biolimus A9 | Hypersensitivity Sirolimus | Medical contraindication Sirolimus | Contrast media allergy | Medical contraindication Contrast Media
Item
1. the patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, prasugrel, ticagrelor, biolimus, sirolimus, contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
boolean
C0571776 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0004058 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0070166 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0055729 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0055729 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C1620287 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C1620287 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C1999375 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C1999375 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C4310325 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C4310325 (UMLS CUI [14,2])
C0020517 (UMLS CUI [15,1])
C0072980 (UMLS CUI [15,2])
C1301624 (UMLS CUI [16,1])
C0072980 (UMLS CUI [16,2])
C0570562 (UMLS CUI [17])
C1301624 (UMLS CUI [18,1])
C0009924 (UMLS CUI [18,2])
Biolimus A9 Intravenous Systemic | Sirolimus Intravenous Systemic
Item
2. systemic (intravenous) biolimus or sirolimus use within 12 months.
boolean
C4310325 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0072980 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
Childbearing Potential Planned Pregnancy Possible | Exception Pregnancy test negative
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 [1,1])
C0032992 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Bleeding tendency | Blood Coagulation Disorders | Heparin-induced thrombocytopenia | Hemogram Abnormal | Hemoglobin measurement | Platelet Count measurement | Blood Transfusion Refused
Item
4. history of bleeding diathesis, known coagulopathy (including heparin- induced thrombocytopenia), abnormal hemogram (hb<10g/dl or plt count <100,000/μl) or will refuse blood transfusions
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0272285 (UMLS CUI [3])
C0200631 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0005841 (UMLS CUI [7,1])
C1705116 (UMLS CUI [7,2])
Left ventricular systolic dysfunction | Left ventricular ejection fraction | Shock, Cardiogenic
Item
5. patients with severe lv systolic dysfunction (lvef<25%) or cardiogenic shock
boolean
C1277187 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0036980 (UMLS CUI [3])
Gastrointestinal Hemorrhage | Genitourinary tract hemorrhage | Major surgery
Item
6. gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.
boolean
C0017181 (UMLS CUI [1])
C0919591 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Comorbidity | Exception Heart Diseases | Life Expectancy | Protocol Compliance Lacking
Item
7. 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])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
C0525058 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | End Point Primary Incomplete
Item
8. 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])
C2349179 (UMLS CUI [4,1])
C0205225 (UMLS CUI [4,2])
C0205257 (UMLS CUI [4,3])
Heart failure Symptomatic
Item
9. symptomatic heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
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