ID

28616

Beschreibung

Sprinter Legend Balloon Catheter; ODM derived from: https://clinicaltrials.gov/show/NCT00961311

Link

https://clinicaltrials.gov/show/NCT00961311

Stichworte

Versionen (1)
  1. 24.01.18 24.01.18 -
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See clinicaltrials.gov

Hochgeladen am

24. Januar 2018

DOI

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Eligibility Coronary Artery Disease NCT00961311

Englisch

Eligibility Coronary Artery Disease NCT00961311

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is greater than18 years of age and able to give informed consent.
Beschreibung

Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (pci).
Beschreibung

Lesion Stenotic Coronary artery | Bypass graft stenosis | Appropriateness Percutaneous Coronary Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0333181
UMLS CUI [1,3]
C0205042
UMLS CUI [2]
C4087532
UMLS CUI [3,1]
C0814634
UMLS CUI [3,2]
C1532338
the patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study.
Beschreibung

Single coronary vessel disease | Multiple vessel coronary artery disease | Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0581374
UMLS CUI [2]
C3805196
UMLS CUI [3]
C0151744
UMLS CUI [4]
C0340288
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0340291
UMLS CUI [7,1]
C0039593
UMLS CUI [7,2]
C0205245
UMLS CUI [7,3]
C1514241
female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
patient or patient'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 institutional review board (irb) 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
patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment.
Beschreibung

Myocardial Ischemia Symptomatic | Etiology Lesion Stenotic Coronary artery | Etiology Bypass graft stenosis | Appropriateness Therapeutic procedure Percutaneous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0333181
UMLS CUI [2,4]
C0205042
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C4087532
UMLS CUI [4,1]
C0814634
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0522523
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
Beschreibung

Aspirin allergy | Heparin allergy | Hypersensitivity Bivalirudin | Hypersensitivity Antiplatelet Agents | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication Bivalirudin | Medical contraindication Antiplatelet Agents | 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]
C0085826
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0004057
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0019134
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0168273
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0085826
UMLS CUI [9,1]
C0570562
UMLS CUI [9,2]
C0033045
UMLS CUI [9,3]
C1272705
a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: q wave myocardial infarction or non-q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (ck-mb) or troponin elevated above the institution's upper limit of normal).
Beschreibung

Myocardial Infarction | Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Creatine Kinase MB Isoenzyme Elevated | Troponin increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0582803
UMLS CUI [3]
C0542269
UMLS CUI [4,1]
C0010290
UMLS CUI [4,2]
C3163633
UMLS CUI [5]
C1141948
during the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc.
Beschreibung

Target Lesion Requirement Additional Therapy | Cutting balloon angioplasty device | Atherectomy | Lasers | Thrombectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1706712
UMLS CUI [2]
C1269809
UMLS CUI [3]
C0162513
UMLS CUI [4]
C0023089
UMLS CUI [5]
C0162578
history of 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
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
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
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00961311

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
patient is greater than18 years of age and able to give informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Lesion Stenotic Coronary artery | Bypass graft stenosis | Appropriateness Percutaneous Coronary Intervention
Item
patient with stenotic lesions in coronary arteries or bypass graft stenosis that are suitable for percutaneous coronary intervention (pci).
boolean
C0221198 (UMLS CUI [1,1])
C0333181 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C4087532 (UMLS CUI [2])
C0814634 (UMLS CUI [3,1])
C1532338 (UMLS CUI [3,2])
Single coronary vessel disease | Multiple vessel coronary artery disease | Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive
Item
the patient has single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study.
boolean
C0581374 (UMLS CUI [1])
C3805196 (UMLS CUI [2])
C0151744 (UMLS CUI [3])
C0340288 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0340291 (UMLS CUI [6])
C0039593 (UMLS CUI [7,1])
C0205245 (UMLS CUI [7,2])
C1514241 (UMLS CUI [7,3])
Childbearing Potential Pregnancy test negative
Item
female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
patient or patient'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 institutional review board (irb) of the respective investigational site.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Myocardial Ischemia Symptomatic | Etiology Lesion Stenotic Coronary artery | Etiology Bypass graft stenosis | Appropriateness Therapeutic procedure Percutaneous
Item
patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft stenosis that are amenable to percutaneous treatment.
boolean
C0151744 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0333181 (UMLS CUI [2,3])
C0205042 (UMLS CUI [2,4])
C0015127 (UMLS CUI [3,1])
C4087532 (UMLS CUI [3,2])
C0814634 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0522523 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Aspirin allergy | Heparin allergy | Hypersensitivity Bivalirudin | Hypersensitivity Antiplatelet Agents | Medical contraindication Aspirin | Medical contraindication Heparin | Medical contraindication Bivalirudin | Medical contraindication Antiplatelet Agents | Contrast media allergy Premedication Unsuccessful
Item
a known hypersensitivity or contraindication to aspirin, heparin, or bivalirudin, anti-platelet medications, or 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])
C0085826 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0004057 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0019134 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0168273 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0085826 (UMLS CUI [8,2])
C0570562 (UMLS CUI [9,1])
C0033045 (UMLS CUI [9,2])
C1272705 (UMLS CUI [9,3])
Creatinine measurement, serum
Item
a serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
boolean
C0201976 (UMLS CUI [1])
Myocardial Infarction | Acute Q wave myocardial infarction | Non-Q wave myocardial infarction | Creatine Kinase MB Isoenzyme Elevated | Troponin increased
Item
evidence of an acute myocardial infarction within 72 hours of the intended index procedure (defined as: q wave myocardial infarction or non-q wave myocardial infarction having creatine kinase myocardial-band isoenzyme (ck-mb) or troponin elevated above the institution's upper limit of normal).
boolean
C0027051 (UMLS CUI [1])
C0582803 (UMLS CUI [2])
C0542269 (UMLS CUI [3])
C0010290 (UMLS CUI [4,1])
C3163633 (UMLS CUI [4,2])
C1141948 (UMLS CUI [5])
Target Lesion Requirement Additional Therapy | Cutting balloon angioplasty device | Atherectomy | Lasers | Thrombectomy
Item
during the index procedure, the target lesion requires additional treatment with a cutting balloon, any artherectomy, any laser, thrombectomy, etc.
boolean
C2986546 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1706712 (UMLS CUI [1,3])
C1269809 (UMLS CUI [2])
C0162513 (UMLS CUI [3])
C0023089 (UMLS CUI [4])
C0162578 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of 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
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
history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0749628 (UMLS CUI [3])
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