ID

16819

Beschreibung

Treatment of Bifurcated Coronary Lesions With Cypher™-Stent; ODM derived from: https://clinicaltrials.gov/show/NCT00288535

Link

https://clinicaltrials.gov/show/NCT00288535

Stichworte

Versionen (1)
  1. 08.08.16 08.08.16 -
Hochgeladen am

8. August 2016

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00288535

Englisch

Eligibility Coronary Artery Disease NCT00288535

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the target vessel must meet the following criteria:
Beschreibung

Inclusion

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
1. bifurcated lesion type 1, 2, 3 or 4 of a native coronary artery with a reference vessel diameter of 2.5 mm to 4.0 mm in the main branch and of ≥ 2.25 mm in the side branch.
Beschreibung

bifurcated lesion of a native coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299363
UMLS CUI [1,2]
C1301408
2. the target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
Beschreibung

Stenosis degree

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C4034225
3. the target lesion has not been previously treated with any interventional procedure.
Beschreibung

previously untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C1299363
4. the target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
Beschreibung

Feasible for stent implantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0940860
UMLS CUI [2]
C0002997
UMLS CUI [3]
C1611184
UMLS CUI [4]
C0009488
2. patient has stable or unstable angina pectoris (ccs classification i or greater) or a positive stress test for ischemia.
Beschreibung

stable or unstable angina pectoris or a positive stress test for ischemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C0015260
3. patient must be ≥ 18 years of age. 4. female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
Beschreibung

Age, Pregnancy Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032976
5. patient has no other treatment planned within 30 days of the procedure. 6. patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the ethics committee.
Beschreibung

Other treatment, Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0021430
7. patient willing to comply with required post-procedure follow-up.
Beschreibung

Patient compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has had an acute myocardial infarction (> 3x normal ck with presence of ckmb) within 72 hours preceding the index procedure and ck has not returned to normal limits at the time of the procedure.
Beschreibung

Acute Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0201973
2. patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.
Beschreibung

hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070166
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0038126
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0072980
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0009924
3. patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a wbc of <3,000 cells/mm³, or documented or suspected liver disease.
Beschreibung

Platelet count, WBC count, liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0232741
4. patient has a history of bleeding diathesis or coagulopathy. 5. patient has suffered a cva or tia within the past six months. 6. active peptic ulcer or upper gi bleeding within the prior 6 months. 7. patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
Beschreibung

bleeding diathesis or coagulopathy, cva or tia, active peptic ulcer or upper gi bleeding, co-morbidity that may cause patient non-compliance, or is associated with limited life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0030920
UMLS CUI [5]
C0041909
UMLS CUI [6,1]
C1321605
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0009488
UMLS CUI [7]
C0023671
8. patient must be excluded from the study if any of these angiographic criteria are met:
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
1. the target vessel contains intraluminal thrombus.
Beschreibung

Thrombus

Datentyp

boolean

Alias
UMLS CUI [1]
C0087086
2. the target lesion is located in the left main coronary artery.
Beschreibung

target lesion located in the left main coronary artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449685
UMLS CUI [1,2]
C1261082
3. the target lesion or vessel shows angiographic evidence of severe calcification.
Beschreibung

Calcification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1611184
UMLS CUI [1,2]
C0449618
4. the patient has undergone previous pci to the target vessel within 6 months.
Beschreibung

previous PCI

Datentyp

boolean

Alias
UMLS CUI [1]
C1532338
5. pre treatment of the lesion is done with a technique other than balloon angioplasty (e.g. rotablation).
Beschreibung

Pre treatment of the lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3640041
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00288535

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion
Item
1. the target vessel must meet the following criteria:
boolean
C1512693 (UMLS CUI [1])
bifurcated lesion of a native coronary artery
Item
1. bifurcated lesion type 1, 2, 3 or 4 of a native coronary artery with a reference vessel diameter of 2.5 mm to 4.0 mm in the main branch and of ≥ 2.25 mm in the side branch.
boolean
C1299363 (UMLS CUI [1,1])
C1301408 (UMLS CUI [1,2])
Stenosis degree
Item
2. the target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
boolean
C0242231 (UMLS CUI [1,1])
C4034225 (UMLS CUI [1,2])
previously untreated
Item
3. the target lesion has not been previously treated with any interventional procedure.
boolean
C0332155 (UMLS CUI [1,1])
C1299363 (UMLS CUI [1,2])
Feasible for stent implantation
Item
4. the target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
boolean
C0940860 (UMLS CUI [1])
C0002997 (UMLS CUI [2])
C1611184 (UMLS CUI [3])
C0009488 (UMLS CUI [4])
stable or unstable angina pectoris or a positive stress test for ischemia
Item
2. patient has stable or unstable angina pectoris (ccs classification i or greater) or a positive stress test for ischemia.
boolean
C0002962 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C0015260 (UMLS CUI [2,2])
Age, Pregnancy Test
Item
3. patient must be ≥ 18 years of age. 4. female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
boolean
C0001779 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
Other treatment, Informed Consent
Item
5. patient has no other treatment planned within 30 days of the procedure. 6. patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the ethics committee.
boolean
C0087111 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Patient compliance
Item
7. patient willing to comply with required post-procedure follow-up.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Myocardial Infarction
Item
1. patient has had an acute myocardial infarction (> 3x normal ck with presence of ckmb) within 72 hours preceding the index procedure and ck has not returned to normal limits at the time of the procedure.
boolean
C0155626 (UMLS CUI [1,1])
C0201973 (UMLS CUI [1,2])
hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity
Item
2. patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070166 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0038126 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0072980 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0009924 (UMLS CUI [6,2])
Platelet count, WBC count, liver disease
Item
3. patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a wbc of <3,000 cells/mm³, or documented or suspected liver disease.
boolean
C0005821 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
bleeding diathesis or coagulopathy, cva or tia, active peptic ulcer or upper gi bleeding, co-morbidity that may cause patient non-compliance, or is associated with limited life expectancy
Item
4. patient has a history of bleeding diathesis or coagulopathy. 5. patient has suffered a cva or tia within the past six months. 6. active peptic ulcer or upper gi bleeding within the prior 6 months. 7. patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
boolean
C0005779 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C0041909 (UMLS CUI [5])
C1321605 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0009488 (UMLS CUI [6,3])
C0023671 (UMLS CUI [7])
Exclusion Criteria
Item
8. patient must be excluded from the study if any of these angiographic criteria are met:
boolean
C0680251 (UMLS CUI [1])
Thrombus
Item
1. the target vessel contains intraluminal thrombus.
boolean
C0087086 (UMLS CUI [1])
target lesion located in the left main coronary artery
Item
2. the target lesion is located in the left main coronary artery.
boolean
C0449685 (UMLS CUI [1,1])
C1261082 (UMLS CUI [1,2])
Calcification
Item
3. the target lesion or vessel shows angiographic evidence of severe calcification.
boolean
C1611184 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
previous PCI
Item
4. the patient has undergone previous pci to the target vessel within 6 months.
boolean
C1532338 (UMLS CUI [1])
Pre treatment of the lesion
Item
5. pre treatment of the lesion is done with a technique other than balloon angioplasty (e.g. rotablation).
boolean
C0087111 (UMLS CUI [1,1])
C3640041 (UMLS CUI [1,2])
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