ID

32002

Beschreibung

The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts; ODM derived from: https://clinicaltrials.gov/show/NCT00453518

Link

https://clinicaltrials.gov/show/NCT00453518

Stichworte

Versionen (1)
  1. 11.10.18 11.10.18 -
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See clinicaltrials.gov

Hochgeladen am

11. Oktober 2018

DOI

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Eligibility Saphenous Vein Graft Disease NCT00453518

Englisch

Eligibility Saphenous Vein Graft Disease NCT00453518

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
candidate for percutaneous transluminal coronary angioplasty (ptca), stenting and emergent coronary artery bypass graft (cabg).
Beschreibung

Patient Appropriate PTCA | Patient Appropriate Stenting | Patient Appropriate Emergency CABG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2936173
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
myocardial ischemia as evidenced by one or more of the following:
Beschreibung

Myocardial Ischemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
diagnosis of stable or unstable angina pectoris
Beschreibung

Stable angina | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2]
C0002965
ecg changes consistent with ischemia
Beschreibung

ECG changes Consistent with Ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0855329
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0022116
positive functional study
Beschreibung

Heart Function Tests Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018803
UMLS CUI [1,2]
C1514241
recent myocardial infarction
Beschreibung

Recent myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1998297
lesion(s) is located within svg and is ≥ 50% and < 100% stenosed.
Beschreibung

Lesion Located in Saphenous vein graft | Lesion Stenosed Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0729538
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0333181
UMLS CUI [2,3]
C0439165
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical criteria:
Beschreibung

Criteria Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205210
myocardial infarction with documented total ck-mb > 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
Beschreibung

Myocardial Infarction With Increased CK-MB | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1834663
UMLS CUI [2]
C0027051
undergone cardiac surgery within the past 60 days.
Beschreibung

Cardiac Surgery procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0018821
a planned invasive surgical procedure within 30 days.
Beschreibung

Invasive procedures Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038895
UMLS CUI [1,2]
C1301732
the lesion(s) is in an svg that is less than 2 months post-implant.
Beschreibung

Lesion Saphenous vein graft | Status post Implant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0729538
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0021107
left ventricular ejection fraction < 20%.
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
a stroke or transient ischemic neurological attack (tia) within the past 2 months.
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
angiographic criteria:
Beschreibung

Criteria Angiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0002978
the lesion(s) is in an arterial conduit.
Beschreibung

Lesion Conduit Arterial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0441247
UMLS CUI [1,3]
C0221464
lesion is within 10 mm of the proximal anastomosis.
Beschreibung

Lesion Proximal anastomosis site

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0448962
more than two native lesions [in addition to the svg lesion(s)] that need to be treated at the index procedure.
Beschreibung

Lesion Native Quantity Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332121
more than two svgs that need to be treated at the index procedure.
Beschreibung

Saphenous vein graft Quantity Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332121
chronic total occlusion of a target lesion.
Beschreibung

Chronic Total Occlusion Target Lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3275069
UMLS CUI [1,2]
C2986546
the svg lesion(s) requires treatment with a large device other than ptca prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
Beschreibung

Saphenous vein graft Lesion | Therapeutic aspects Medical Device Large | Exception PTCA | Status pre- Placement of stent | Directional Coronary Atherectomy | Lasers, Excimer | Rotational Atherectomy | Rheolytic Thrombectomy Catheters | Brachytherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C0221198
UMLS CUI [2,1]
C0039798
UMLS CUI [2,2]
C0025080
UMLS CUI [2,3]
C0549177
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2936173
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C0522776
UMLS CUI [5]
C0162654
UMLS CUI [6]
C0392265
UMLS CUI [7]
C0162655
UMLS CUI [8]
C0878963
UMLS CUI [9]
C0006098
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Ähnliche Modelle

Eligibility Saphenous Vein Graft Disease NCT00453518

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Patient Appropriate PTCA | Patient Appropriate Stenting | Patient Appropriate Emergency CABG
Item
candidate for percutaneous transluminal coronary angioplasty (ptca), stenting and emergent coronary artery bypass graft (cabg).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2936173 (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
Item
myocardial ischemia as evidenced by one or more of the following:
boolean
C0151744 (UMLS CUI [1])
Stable angina | Angina, Unstable
Item
diagnosis of stable or unstable angina pectoris
boolean
C0340288 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
ECG changes Consistent with Ischemia
Item
ecg changes consistent with ischemia
boolean
C0855329 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0022116 (UMLS CUI [1,3])
Heart Function Tests Positive
Item
positive functional study
boolean
C0018803 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Recent myocardial infarction
Item
recent myocardial infarction
boolean
C1998297 (UMLS CUI [1])
Lesion Located in Saphenous vein graft | Lesion Stenosed Percentage
Item
lesion(s) is located within svg and is ≥ 50% and < 100% stenosed.
boolean
C0221198 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0729538 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0333181 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Criteria Clinical
Item
clinical criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Myocardial Infarction With Increased CK-MB | Myocardial Infarction
Item
myocardial infarction with documented total ck-mb > 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
boolean
C0027051 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1834663 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
Cardiac Surgery procedures
Item
undergone cardiac surgery within the past 60 days.
boolean
C0018821 (UMLS CUI [1])
Invasive procedures Planned
Item
a planned invasive surgical procedure within 30 days.
boolean
C0038895 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Lesion Saphenous vein graft | Status post Implant
Item
the lesion(s) is in an svg that is less than 2 months post-implant.
boolean
C0221198 (UMLS CUI [1,1])
C0729538 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction < 20%.
boolean
C0428772 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
a stroke or transient ischemic neurological attack (tia) within the past 2 months.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Criteria Angiography
Item
angiographic criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Lesion Conduit Arterial
Item
the lesion(s) is in an arterial conduit.
boolean
C0221198 (UMLS CUI [1,1])
C0441247 (UMLS CUI [1,2])
C0221464 (UMLS CUI [1,3])
Lesion Proximal anastomosis site
Item
lesion is within 10 mm of the proximal anastomosis.
boolean
C0221198 (UMLS CUI [1,1])
C0448962 (UMLS CUI [1,2])
Lesion Native Quantity Treatment required for
Item
more than two native lesions [in addition to the svg lesion(s)] that need to be treated at the index procedure.
boolean
C0221198 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332121 (UMLS CUI [1,4])
Saphenous vein graft Quantity Treatment required for
Item
more than two svgs that need to be treated at the index procedure.
boolean
C0729538 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Chronic Total Occlusion Target Lesion
Item
chronic total occlusion of a target lesion.
boolean
C3275069 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
Saphenous vein graft Lesion | Therapeutic aspects Medical Device Large | Exception PTCA | Status pre- Placement of stent | Directional Coronary Atherectomy | Lasers, Excimer | Rotational Atherectomy | Rheolytic Thrombectomy Catheters | Brachytherapy
Item
the svg lesion(s) requires treatment with a large device other than ptca prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
boolean
C0729538 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0039798 (UMLS CUI [2,1])
C0025080 (UMLS CUI [2,2])
C0549177 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2936173 (UMLS CUI [3,2])
C0332152 (UMLS CUI [4,1])
C0522776 (UMLS CUI [4,2])
C0162654 (UMLS CUI [5])
C0392265 (UMLS CUI [6])
C0162655 (UMLS CUI [7])
C0878963 (UMLS CUI [8])
C0006098 (UMLS CUI [9])
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