ID

28714

Beschreibung

The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries; ODM derived from: https://clinicaltrials.gov/show/NCT01025869

Link

https://clinicaltrials.gov/show/NCT01025869

Stichworte

Versionen (1)
  1. 26.01.18 26.01.18 -
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See clinicaltrials.gov

Hochgeladen am

26. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT01025869

Englisch

Eligibility Coronary Artery Disease NCT01025869

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is ≥ 18 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient is an acceptable candidate for percutaneous coronary intervention (pci), stenting, and emergent coronary artery bypass graft (cabg) surgery
Beschreibung

Patient Appropriate Percutaneous Coronary Intervention | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C2348535
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0013956
UMLS CUI [3,4]
C0010055
3. patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
Beschreibung

Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0340291
UMLS CUI [5,1]
C0039593
UMLS CUI [5,2]
C0205245
UMLS CUI [5,3]
C1514241
4. female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
5. patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the hospital research ethics committee (hrec) of the respective investigational site
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
6. patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
angiographic:
Beschreibung

Angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0002978
1. patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
Beschreibung

Target Lesion Single | Lesion Quantity | Location Coronary arteries Separate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0205042
UMLS CUI [3,3]
C0443299
2. if a non-target lesion is treated, it must be treated first and only with commercially available ptca balloons and/or stents. post pci of the non-target vessel, all of the following conditions must be met:
Beschreibung

Coronary Balloon Angioplasty Lesion | PTCA Stent Lesion | Exception Target Lesion | PCI Vessel | Exception Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002997
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C2936173
UMLS CUI [2,2]
C0038257
UMLS CUI [2,3]
C0221198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2986546
UMLS CUI [4,1]
C1532338
UMLS CUI [4,2]
C0005847
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0449618
residual diameter stenosis <10%
Beschreibung

Percent Diameter Stenosis Measurement Residual

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3897965
UMLS CUI [1,2]
C1609982
absence of any angiographic complications
Beschreibung

Absence Complication Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0002978
absence of ischaemic symptoms
Beschreibung

Absence Symptoms Ischemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0475224
absence of significant new arrhythmia or ecg monitoring changes suggestive of ischaemia
Beschreibung

Absence Cardiac Arrhythmia New | Absence ECG changes Suggestive of Ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0003811
UMLS CUI [1,3]
C0205314
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0855329
UMLS CUI [2,3]
C0332299
UMLS CUI [2,4]
C0022116
3. target lesion must be a de novo lesion in native coronary artery
Beschreibung

Target Lesion de novo Coronary artery Native

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
4. target lesion must be ≤ 22 mm in length
Beschreibung

Target Lesion Length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
5. target lesion must have a stenosis of ≥ 50% and < 100%
Beschreibung

Target Lesion Stenosis Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1261287
UMLS CUI [1,3]
C0439165
6. target vessel must have a reference vessel diameter (rvd) appropriate for treatment with a of 3.0mm or3.5 mm stent
Beschreibung

Target vessel | Reference Vessel Diameter | Appropriateness Therapeutic procedure Length of stent

Datentyp

boolean

Alias
UMLS CUI [1]
C0449618
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0814634
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0449462
7. target vessel must have a thrombolysis in myocardial infarction (timi) flow ≥ 2
Beschreibung

Target vessel TIMI Flow Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C3272266
UMLS CUI [1,3]
C4263591
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
Beschreibung

Aspirin allergy | Heparin allergy | Hypersensitivity bivalirudin | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Cobalt | Hypersensitivity Chromium | Hypersensitivity Drug-Coated Stents | Hypersensitivity Fatty Acids | Hypersensitivity Glycerides | Hypersensitivity Alpha Tocopherol | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication bivalirudin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Cobalt | Medical contraindication Chromium | Medical contraindication Drug-Coated Stents | Medical contraindication Fatty Acids | Medical contraindication Glycerides | Medical contraindication Alpha Tocopherol | Contrast media allergy Premedication Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0168273
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0070166
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0040207
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0009148
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0008574
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C1445093
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0015684
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0017860
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0969677
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C0004057
UMLS CUI [13,1]
C1301624
UMLS CUI [13,2]
C0019134
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C0168273
UMLS CUI [15,1]
C1301624
UMLS CUI [15,2]
C0070166
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C0040207
UMLS CUI [17,1]
C1301624
UMLS CUI [17,2]
C0009148
UMLS CUI [18,1]
C1301624
UMLS CUI [18,2]
C0008574
UMLS CUI [19,1]
C1301624
UMLS CUI [19,2]
C1445093
UMLS CUI [20,1]
C1301624
UMLS CUI [20,2]
C0015684
UMLS CUI [21,1]
C1301624
UMLS CUI [21,2]
C0017860
UMLS CUI [22,1]
C1301624
UMLS CUI [22,2]
C0969677
UMLS CUI [23,1]
C0570562
UMLS CUI [23,2]
C0033045
UMLS CUI [23,3]
C1272705
2. history of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
Beschreibung

Allergic Reaction zotarolimus | Allergic Reaction Sirolimus | Allergic Reaction Tacrolimus | Allergic Reaction everolimus | Allergic Reaction Analogue | Allergic Reaction Derivative | Hypersensitivity zotarolimus | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | Hypersensitivity everolimus | Hypersensitivity Analogue | Hypersensitivity Derivative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1700035
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0072980
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0085149
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0541315
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0243071
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C1527240
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C1700035
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0072980
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0085149
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0541315
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0243071
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C1527240
3. platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (wbc) count < 3,000 cells/mm³ within 7 days prior to index procedure
Beschreibung

Platelet Count measurement | White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0023508
4. serum creatinine level 170 micromol/l within 7 days prior to index procedure
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
5. evidence of an acute myocardial infarction (mi) within 72 hours of the intended trial procedure (defined as: q wave myocardial infarction (qwmi) or non-q wave myocardial infarction (nqwmi) having ck enzymes > 2x the laboratory upper limit of normal with the presence of an elevated ck-mb (any amount above the laboratory upper limit of normal)
Beschreibung

Myocardial Infarction | Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase | Creatine kinase MB increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0582803
UMLS CUI [3]
C0542269
UMLS CUI [4]
C0151576
UMLS CUI [5]
C0861005
6. previous pci of the target vessel within 9 months prior to the procedure
Beschreibung

Percutaneous Coronary Intervention Previous Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0449618
7. any planned additional pci procedure within 30 days post-index procedure and/or planned pci of the target vessel within 12 months post-procedure
Beschreibung

Percutaneous Coronary Intervention Additional Planned | Percutaneous Coronary Intervention Planned Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0449618
8. during the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than ptca prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
Beschreibung

Lesion Requirement Medical Device Therapeutic procedure | Exception Percutaneous Transluminal Coronary Angioplasty | Statud pre- Placement of stent | Cutting balloon | Atherectomy | Thrombectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2936173
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0522776
UMLS CUI [4]
C1269809
UMLS CUI [5]
C0162513
UMLS CUI [6]
C0162578
9. left ventricular ejection fraction (lvef) < 30% if evaluated, or clinical evidence of significant congestive heart failure (nyha class iii or iv) within the prior 30 days
Beschreibung

Left ventricular ejection fraction | Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
10. history of a stroke or transient ischemic attack (tia) within the prior 6 months
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
11. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
Beschreibung

Peptic Ulcer | Upper gastrointestinal hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0041909
12. history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Beschreibung

Bleeding tendency | Blood Coagulation Disorders | Transfusion blood refusal

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0749628
13. concurrent medical condition with a life expectancy of less than 12 months
Beschreibung

Other medical condition | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2]
C0023671
14. any previous treatment of the target vessel(s) for restenosis, including brachytherapy
Beschreibung

Therapeutic procedure Target vessel Restenosis | Brachytherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0449618
UMLS CUI [1,3]
C0333186
UMLS CUI [2]
C0006098
16. any condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study 17. currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, ivus or other coronary artery imaging procedures
Beschreibung

Condition Interferes with Study Subject Participation Status | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Incomplete | Clinical Trial Interferes with End Point Current | Clinical Trial Requirement Coronary angiography | Clinical Trial Requirement IVUS | Clinical Trial Requirement Coronary artery Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
UMLS CUI [5,1]
C2986535
UMLS CUI [5,2]
C0205257
UMLS CUI [6,1]
C0008976
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2349179
UMLS CUI [6,4]
C0521116
UMLS CUI [7,1]
C0008976
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0085532
UMLS CUI [8,1]
C0008976
UMLS CUI [8,2]
C1514873
UMLS CUI [8,3]
C0206520
UMLS CUI [9,1]
C0008976
UMLS CUI [9,2]
C1514873
UMLS CUI [9,3]
C0205042
UMLS CUI [9,4]
C0011923
angiographic:
Beschreibung

Angiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0002978
1. target lesion is located in native vessel distal to anastomosis with a saphenous vein graft or a left/right internal mammary artery (lima/rima) bypass with more than 40% diameter stenosis anywhere within the graft
Beschreibung

Target Lesion Location Vessel Native | Location Distal Anastomosis | Saphenous vein graft | Coronary artery bypass - left internal mammary artery [LIMA] graft | Coronary artery bypass - right internal mammary artery [RIMA] graft | Percent Diameter Stenosis Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0302891
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205108
UMLS CUI [2,3]
C0500470
UMLS CUI [3]
C0729538
UMLS CUI [4]
C0841999
UMLS CUI [5]
C0842000
UMLS CUI [6]
C3897965
2. previous stenting in the target vessel.
Beschreibung

Stenting Previous Target vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0449618
3. the target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line qca
Beschreibung

Target vessel Lesion Percent Diameter Stenosis Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C3897965
4. the target vessel has evidence of thrombus
Beschreibung

Target vessel Thrombus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0087086
5. the target vessel is excessively tortuous (two bends > 90º to reach the target lesion)
Beschreibung

Target vessel Tortuous Excessive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C4068863
UMLS CUI [1,3]
C0442802
6. the target lesion has any of the following characteristics:
Beschreibung

Target Lesion Characteristics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1521970
lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending (lad) or left circumflex (lcx)
Beschreibung

Lesion Location Aorta Ostium | Left main coronary artery Lesion Without Protection | Distance Left anterior descending artery | Distance Left circumflex artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0003483
UMLS CUI [1,4]
C0444567
UMLS CUI [2,1]
C1261082
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C1545588
UMLS CUI [3,1]
C0012751
UMLS CUI [3,2]
C0226032
UMLS CUI [4,1]
C0012751
UMLS CUI [4,2]
C0226037
involves a side branch > 2.0 mm in diameter
Beschreibung

Involvement Side Branch Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C1253959
UMLS CUI [1,4]
C1301886
is at or distal to a > 45º bend in the vessel
Beschreibung

Tortuosity Vessel

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0333076
UMLS CUI [1,2]
C0005847
is severely calcified
Beschreibung

Calcified Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175895
UMLS CUI [1,2]
C0205082
7. unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)
Beschreibung

Left main coronary artery disease Without Protection | Obstruction Percentage Left main coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299433
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C1545588
UMLS CUI [2,1]
C0028778
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1261082
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT01025869

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Patient Appropriate Percutaneous Coronary Intervention | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery
Item
2. patient is an acceptable candidate for percutaneous coronary intervention (pci), stenting, and emergent coronary artery bypass graft (cabg) surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2348535 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0013956 (UMLS CUI [3,3])
C0010055 (UMLS CUI [3,4])
Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive
Item
3. patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0039593 (UMLS CUI [5,1])
C0205245 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
Childbearing Potential Pregnancy test negative
Item
4. female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
5. patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the hospital research ethics committee (hrec) of the respective investigational site
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
6. patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed
boolean
C0525058 (UMLS CUI [1])
Angiography
Item
angiographic:
boolean
C0002978 (UMLS CUI [1])
Target Lesion Single | Lesion Quantity | Location Coronary arteries Separate
Item
1. patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
boolean
C2986546 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C0205042 (UMLS CUI [3,2])
C0443299 (UMLS CUI [3,3])
Coronary Balloon Angioplasty Lesion | PTCA Stent Lesion | Exception Target Lesion | PCI Vessel | Exception Target vessel
Item
2. if a non-target lesion is treated, it must be treated first and only with commercially available ptca balloons and/or stents. post pci of the non-target vessel, all of the following conditions must be met:
boolean
C0002997 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2936173 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2986546 (UMLS CUI [3,2])
C1532338 (UMLS CUI [4,1])
C0005847 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0449618 (UMLS CUI [5,2])
Percent Diameter Stenosis Measurement Residual
Item
residual diameter stenosis <10%
boolean
C3897965 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
Absence Complication Angiography
Item
absence of any angiographic complications
boolean
C0332197 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0002978 (UMLS CUI [1,3])
Absence Symptoms Ischemic
Item
absence of ischaemic symptoms
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0475224 (UMLS CUI [1,3])
Absence Cardiac Arrhythmia New | Absence ECG changes Suggestive of Ischemia
Item
absence of significant new arrhythmia or ecg monitoring changes suggestive of ischaemia
boolean
C0332197 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0855329 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C0022116 (UMLS CUI [2,4])
Target Lesion de novo Coronary artery Native
Item
3. target lesion must be a de novo lesion in native coronary artery
boolean
C2986546 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Target Lesion Length
Item
4. target lesion must be ≤ 22 mm in length
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Target Lesion Stenosis Percentage
Item
5. target lesion must have a stenosis of ≥ 50% and < 100%
boolean
C2986546 (UMLS CUI [1,1])
C1261287 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Target vessel | Reference Vessel Diameter | Appropriateness Therapeutic procedure Length of stent
Item
6. target vessel must have a reference vessel diameter (rvd) appropriate for treatment with a of 3.0mm or3.5 mm stent
boolean
C0449618 (UMLS CUI [1])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0814634 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0449462 (UMLS CUI [3,3])
Target vessel TIMI Flow Grade
Item
7. target vessel must have a thrombolysis in myocardial infarction (timi) flow ≥ 2
boolean
C0449618 (UMLS CUI [1,1])
C3272266 (UMLS CUI [1,2])
C4263591 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Aspirin allergy | Heparin allergy | Hypersensitivity bivalirudin | Hypersensitivity clopidogrel | Hypersensitivity Ticlopidine | Hypersensitivity Cobalt | Hypersensitivity Chromium | Hypersensitivity Drug-Coated Stents | Hypersensitivity Fatty Acids | Hypersensitivity Glycerides | Hypersensitivity Alpha Tocopherol | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication bivalirudin | Medical contraindication clopidogrel | Medical contraindication Ticlopidine | Medical contraindication Cobalt | Medical contraindication Chromium | Medical contraindication Drug-Coated Stents | Medical contraindication Fatty Acids | Medical contraindication Glycerides | Medical contraindication Alpha Tocopherol | Contrast media allergy Premedication Unsuccessful
Item
1. known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0168273 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0070166 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0040207 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0009148 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0008574 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C1445093 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0015684 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0017860 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0969677 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C0004057 (UMLS CUI [12,2])
C1301624 (UMLS CUI [13,1])
C0019134 (UMLS CUI [13,2])
C1301624 (UMLS CUI [14,1])
C0168273 (UMLS CUI [14,2])
C1301624 (UMLS CUI [15,1])
C0070166 (UMLS CUI [15,2])
C1301624 (UMLS CUI [16,1])
C0040207 (UMLS CUI [16,2])
C1301624 (UMLS CUI [17,1])
C0009148 (UMLS CUI [17,2])
C1301624 (UMLS CUI [18,1])
C0008574 (UMLS CUI [18,2])
C1301624 (UMLS CUI [19,1])
C1445093 (UMLS CUI [19,2])
C1301624 (UMLS CUI [20,1])
C0015684 (UMLS CUI [20,2])
C1301624 (UMLS CUI [21,1])
C0017860 (UMLS CUI [21,2])
C1301624 (UMLS CUI [22,1])
C0969677 (UMLS CUI [22,2])
C0570562 (UMLS CUI [23,1])
C0033045 (UMLS CUI [23,2])
C1272705 (UMLS CUI [23,3])
Allergic Reaction zotarolimus | Allergic Reaction Sirolimus | Allergic Reaction Tacrolimus | Allergic Reaction everolimus | Allergic Reaction Analogue | Allergic Reaction Derivative | Hypersensitivity zotarolimus | Hypersensitivity Sirolimus | Hypersensitivity Tacrolimus | Hypersensitivity everolimus | Hypersensitivity Analogue | Hypersensitivity Derivative
Item
2. history of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
boolean
C1527304 (UMLS CUI [1,1])
C1700035 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0085149 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0541315 (UMLS CUI [4,2])
C1527304 (UMLS CUI [5,1])
C0243071 (UMLS CUI [5,2])
C1527304 (UMLS CUI [6,1])
C1527240 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C1700035 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0072980 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0085149 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0541315 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0243071 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C1527240 (UMLS CUI [12,2])
Platelet Count measurement | White Blood Cell Count procedure
Item
3. platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (wbc) count < 3,000 cells/mm³ within 7 days prior to index procedure
boolean
C0032181 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Creatinine measurement, serum
Item
4. serum creatinine level 170 micromol/l within 7 days prior to index procedure
boolean
C0201976 (UMLS CUI [1])
Myocardial Infarction | Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Elevated creatine kinase | Creatine kinase MB increased
Item
5. evidence of an acute myocardial infarction (mi) within 72 hours of the intended trial procedure (defined as: q wave myocardial infarction (qwmi) or non-q wave myocardial infarction (nqwmi) having ck enzymes > 2x the laboratory upper limit of normal with the presence of an elevated ck-mb (any amount above the laboratory upper limit of normal)
boolean
C0027051 (UMLS CUI [1])
C0582803 (UMLS CUI [2])
C0542269 (UMLS CUI [3])
C0151576 (UMLS CUI [4])
C0861005 (UMLS CUI [5])
Percutaneous Coronary Intervention Previous Target vessel
Item
6. previous pci of the target vessel within 9 months prior to the procedure
boolean
C1532338 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Percutaneous Coronary Intervention Additional Planned | Percutaneous Coronary Intervention Planned Target vessel
Item
7. any planned additional pci procedure within 30 days post-index procedure and/or planned pci of the target vessel within 12 months post-procedure
boolean
C1532338 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0449618 (UMLS CUI [2,3])
Lesion Requirement Medical Device Therapeutic procedure | Exception Percutaneous Transluminal Coronary Angioplasty | Statud pre- Placement of stent | Cutting balloon | Atherectomy | Thrombectomy
Item
8. during the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than ptca prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
boolean
C0221198 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C2936173 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0522776 (UMLS CUI [3,2])
C1269809 (UMLS CUI [4])
C0162513 (UMLS CUI [5])
C0162578 (UMLS CUI [6])
Left ventricular ejection fraction | Congestive heart failure New York Heart Association Classification
Item
9. left ventricular ejection fraction (lvef) < 30% if evaluated, or clinical evidence of significant congestive heart failure (nyha class iii or iv) within the prior 30 days
boolean
C0428772 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
10. history of a stroke or transient ischemic attack (tia) within the prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Peptic Ulcer | Upper gastrointestinal hemorrhage
Item
11. active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months
boolean
C0030920 (UMLS CUI [1])
C0041909 (UMLS CUI [2])
Bleeding tendency | Blood Coagulation Disorders | Transfusion blood refusal
Item
12. history of bleeding diathesis or coagulopathy or will refuse blood transfusions
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0749628 (UMLS CUI [3])
Other medical condition | Life Expectancy
Item
13. concurrent medical condition with a life expectancy of less than 12 months
boolean
C3843040 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Therapeutic procedure Target vessel Restenosis | Brachytherapy
Item
14. any previous treatment of the target vessel(s) for restenosis, including brachytherapy
boolean
C0087111 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
C0333186 (UMLS CUI [1,3])
C0006098 (UMLS CUI [2])
Condition Interferes with Study Subject Participation Status | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint Incomplete | Clinical Trial Interferes with End Point Current | Clinical Trial Requirement Coronary angiography | Clinical Trial Requirement IVUS | Clinical Trial Requirement Coronary artery Imaging
Item
16. any condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study 17. currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, ivus or other coronary artery imaging procedures
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
C2986535 (UMLS CUI [5,1])
C0205257 (UMLS CUI [5,2])
C0008976 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2349179 (UMLS CUI [6,3])
C0521116 (UMLS CUI [6,4])
C0008976 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0085532 (UMLS CUI [7,3])
C0008976 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0206520 (UMLS CUI [8,3])
C0008976 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C0205042 (UMLS CUI [9,3])
C0011923 (UMLS CUI [9,4])
Angiography
Item
angiographic:
boolean
C0002978 (UMLS CUI [1])
Target Lesion Location Vessel Native | Location Distal Anastomosis | Saphenous vein graft | Coronary artery bypass - left internal mammary artery [LIMA] graft | Coronary artery bypass - right internal mammary artery [RIMA] graft | Percent Diameter Stenosis Measurement
Item
1. target lesion is located in native vessel distal to anastomosis with a saphenous vein graft or a left/right internal mammary artery (lima/rima) bypass with more than 40% diameter stenosis anywhere within the graft
boolean
C2986546 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
C1515974 (UMLS CUI [2,1])
C0205108 (UMLS CUI [2,2])
C0500470 (UMLS CUI [2,3])
C0729538 (UMLS CUI [3])
C0841999 (UMLS CUI [4])
C0842000 (UMLS CUI [5])
C3897965 (UMLS CUI [6])
Stenting Previous Target vessel
Item
2. previous stenting in the target vessel.
boolean
C2348535 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Target vessel Lesion Percent Diameter Stenosis Measurement
Item
3. the target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line qca
boolean
C0449618 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3897965 (UMLS CUI [1,3])
Target vessel Thrombus
Item
4. the target vessel has evidence of thrombus
boolean
C0449618 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
Target vessel Tortuous Excessive
Item
5. the target vessel is excessively tortuous (two bends > 90º to reach the target lesion)
boolean
C0449618 (UMLS CUI [1,1])
C4068863 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
Target Lesion Characteristics
Item
6. the target lesion has any of the following characteristics:
boolean
C2986546 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Lesion Location Aorta Ostium | Left main coronary artery Lesion Without Protection | Distance Left anterior descending artery | Distance Left circumflex artery
Item
lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending (lad) or left circumflex (lcx)
boolean
C0221198 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0003483 (UMLS CUI [1,3])
C0444567 (UMLS CUI [1,4])
C1261082 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C1545588 (UMLS CUI [2,4])
C0012751 (UMLS CUI [3,1])
C0226032 (UMLS CUI [3,2])
C0012751 (UMLS CUI [4,1])
C0226037 (UMLS CUI [4,2])
Involvement Side Branch Diameter
Item
involves a side branch > 2.0 mm in diameter
boolean
C1314939 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1253959 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
Tortuosity Vessel
Item
is at or distal to a > 45º bend in the vessel
boolean
C0333076 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
Calcified Severe
Item
is severely calcified
boolean
C0175895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Left main coronary artery disease Without Protection | Obstruction Percentage Left main coronary artery
Item
7. unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)
boolean
C1299433 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C1545588 (UMLS CUI [1,3])
C0028778 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1261082 (UMLS CUI [2,3])
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