ID

5095

Description

ODM derived from http://clinicaltrials.gov/show/NCT01179984

Link

http://clinicaltrials.gov/show/NCT01179984

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01179984 Peripheral Vascular Disease

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 21 Years
Description

age at least 21 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
Description

The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
Description

Subject agrees to comply with the protocol-mandated follow-up procedures and visits.

Data type

boolean

Alias
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1522577
UMLS CUI 2011AA
C2700391
UMLS CUI 2011AA
C0589121
SNOMED CT 2011_0131
185389009
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
Description

Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.

Data type

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
Description

The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).

Data type

boolean

Alias
UMLS CUI 2011AA
C0023676
SNOMED CT 2011_0131
134436002
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0311395
SNOMED CT 2011_0131
275520000
MedDRA 14.1
10009240
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0475224
SNOMED CT 2011_0131
255426005
UMLS CUI 2011AA
C0234253
SNOMED CT 2011_0131
52598005
MedDRA 14.1
10059073
The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
Description

The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.

Data type

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
C0333186
SNOMED CT 2011_0131
43026009
UMLS CUI 2011AA
CL354751
SNOMED CT 2011_0131
26036001
MedDRA 14.1
10029990
UMLS CUI 2011AA
C0814423
UMLS CUI 2011AA
C2936666
SNOMED CT 2011_0131
5431005
MedDRA 14.1
10057787
UMLS CUI 2011AA
CL371838
The total treated segment(s) must be ≤ 240 mm.
Description

The total treated segment(s) must be ≤ 240 mm.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0441635
SNOMED CT 2011_0131
264193005
The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
Description

The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.

Data type

boolean

Alias
UMLS CUI 2011AA
C0449618
SNOMED CT 2011_0131
246325009
UMLS CUI 2011AA
C1706462
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
Description

There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0005847
SNOMED CT 2011_0131
59820001
LOINC Version 232
MTHU020168
UMLS CUI 2011AA
C0806140
LOINC Version 232
MTHU009126
UMLS CUI 2011AA
C0016504
SNOMED CT 2011_0131
56459004
LOINC Version 232
MTHU002679
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0448227
SNOMED CT 2011_0131
113225006
UMLS CUI 2011AA
C0223895
SNOMED CT 2011_0131
6417001
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
Description

The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
Description

The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).

Data type

boolean

Alias
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C0311395
SNOMED CT 2011_0131
275520000
MedDRA 14.1
10009240
UMLS CUI 2011AA
C1142264
MedDRA 14.1
10058069
UMLS CUI 2011AA
C0205165
SNOMED CT 2011_0131
255606000
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0040300
SNOMED CT 2011_0131
85756007
UMLS CUI 2011AA
C1517945
The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
Description

The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0085826
SNOMED CT 2011_0131
372560006
UMLS CUI 2011AA
C0003280
SNOMED CT 2011_0131
372862008
UMLS CUI 2011AA
C0028013
SNOMED CT 2011_0131
33396006
LOINC Version 232
MTHU003538
UMLS CUI 2011AA
C0040302
SNOMED CT 2011_0131
1166006
LOINC Version 232
MTHU014132
UMLS CUI 2011AA
C0039297
SNOMED CT 2011_0131
45215009
The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
Description

The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0814423
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
UMLS CUI 2011AA
C1504374
MedDRA 14.1
10063542
The subject has a history of bleeding diatheses or coagulopathy.
Description

The subject has a history of bleeding diatheses or coagulopathy.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C0005779
SNOMED CT 2011_0131
64779008
MedDRA 14.1
10009802
ICD-10-CM Version 2010
D68.9
The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
Description

The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
Description

The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C1306571
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10056542
UMLS CUI 2011AA
C0040046
SNOMED CT 2011_0131
64156001
MedDRA 14.1
10043570
UMLS CUI 2011AA
C0041948
SNOMED CT 2011_0131
44730006
MedDRA 14.1
10046369
ICD-10-CM Version 2010
N19
UMLS CUI 2011AA
C0024141
SNOMED CT 2011_0131
55464009
MedDRA 14.1
10042945
ICD-10-CM Version 2010
M32.9
ICD-9-CM Version 2011
710.0
UMLS CUI 2011AA
C0149871
SNOMED CT 2011_0131
128053003
MedDRA 14.1
10051055
ICD-10-CM Version 2010
I82.40
The subject is receiving dialysis or immunosuppressive therapy.
Description

The subject is receiving dialysis or immunosuppressive therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
The subject is participating in an investigational drug or another investigational device study.
Description

The subject is participating in an investigational drug or another investigational device study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of < two years.
Description

The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of < two years.

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1511726
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
Description

The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205231
SNOMED CT 2011_0131
41118005
UMLS CUI 2011AA
C0085096
SNOMED CT 2011_0131
400047006
MedDRA 14.1
10034636
LOINC Version 232
MTHU020791
ICD-10-CM Version 2010
I73.9
ICD-9-CM Version 2011
443.9
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1883719
UMLS CUI 2011AA
C0456642
SNOMED CT 2011_0131
277312002
The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
Description

The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).

Data type

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0002940
SNOMED CT 2011_0131
432119003
MedDRA 14.1
10002329
ICD-10-CM Version 2010
I72.9
ICD-9-CM Version 2011
442.9
UMLS CUI 2011AA
C0005847
SNOMED CT 2011_0131
59820001
LOINC Version 232
MTHU020168
UMLS CUI 2011AA
C0441635
SNOMED CT 2011_0131
264193005
The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
Description

The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.

Data type

boolean

Alias
UMLS CUI 2011AA
CL378222
SNOMED CT 2011_0131
77343006
MedDRA 14.1
10050062
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C2700379
UMLS CUI 2011AA
C0678861
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
C0863745
MedDRA 14.1
10052090
The subject is diagnosed with septicemia at the time of the study procedure.
Description

The subject is diagnosed with septicemia at the time of the study procedure.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0036690
SNOMED CT 2011_0131
105592009
MedDRA 14.1
10040089
LOINC Version 232
MTHU020833
ICD-10-CM Version 2010
A41.9
ICD-9-CM Version 2011
038.9
CTCAE 1105E
E11560
UMLS CUI 2011AA
C2348558
Patients with a stent previously implanted into the target vessel.
Description

Patients with a stent previously implanted into the target vessel.

Data type

boolean

Alias
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
UMLS CUI 2011AA
C0449618
SNOMED CT 2011_0131
246325009
Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.
Description

Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.

Data type

boolean

Alias
UMLS CUI 2011AA
C1511113
UMLS CUI 2011AA
C0302891
SNOMED CT 2011_0131
263818007
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
UMLS CUI 2011AA
C0205107
SNOMED CT 2011_0131
40415009
UMLS CUI 2011AA
C1278953
SNOMED CT 2011_0131
181350008
UMLS CUI 2011AA
C1706086
UMLS CUI 2011AA
C0015385
SNOMED CT 2011_0131
66019005
LOINC Version 232
MTHU001429
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0039798
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 21 Years
Item
age at least 21 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
Item
The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
boolean
C0021430 (UMLS CUI 2011AA)
Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
Item
Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
boolean
C0525058 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
C2700391 (UMLS CUI 2011AA)
C0589121 (UMLS CUI 2011AA)
185389009 (SNOMED CT 2011_0131)
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
Item
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
Item
The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
boolean
C0023676 (UMLS CUI 2011AA)
134436002 (SNOMED CT 2011_0131)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0311395 (UMLS CUI 2011AA)
275520000 (SNOMED CT 2011_0131)
10009240 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0475224 (UMLS CUI 2011AA)
255426005 (SNOMED CT 2011_0131)
C0234253 (UMLS CUI 2011AA)
52598005 (SNOMED CT 2011_0131)
10059073 (MedDRA 14.1)
The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
Item
The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
boolean
C2986546 (UMLS CUI 2011AA)
C1261287 (UMLS CUI 2011AA)
C0333186 (UMLS CUI 2011AA)
43026009 (SNOMED CT 2011_0131)
CL354751 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10029990 (MedDRA 14.1)
C0814423 (UMLS CUI 2011AA)
C2936666 (UMLS CUI 2011AA)
5431005 (SNOMED CT 2011_0131)
10057787 (MedDRA 14.1)
CL371838 (UMLS CUI 2011AA)
The total treated segment(s) must be ≤ 240 mm.
Item
The total treated segment(s) must be ≤ 240 mm.
boolean
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0441635 (UMLS CUI 2011AA)
264193005 (SNOMED CT 2011_0131)
The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
Item
The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
boolean
C0449618 (UMLS CUI 2011AA)
246325009 (SNOMED CT 2011_0131)
C1706462 (UMLS CUI 2011AA)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0814634 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
Item
There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0005847 (UMLS CUI 2011AA)
59820001 (SNOMED CT 2011_0131)
MTHU020168 (LOINC Version 232)
C0806140 (UMLS CUI 2011AA)
MTHU009126 (LOINC Version 232)
C0016504 (UMLS CUI 2011AA)
56459004 (SNOMED CT 2011_0131)
MTHU002679 (LOINC Version 232)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0448227 (UMLS CUI 2011AA)
113225006 (SNOMED CT 2011_0131)
C0223895 (UMLS CUI 2011AA)
6417001 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
Item
The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
boolean
C0021430 (UMLS CUI 2011AA)
The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
Item
The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
boolean
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0311395 (UMLS CUI 2011AA)
275520000 (SNOMED CT 2011_0131)
10009240 (MedDRA 14.1)
C1142264 (UMLS CUI 2011AA)
10058069 (MedDRA 14.1)
C0205165 (UMLS CUI 2011AA)
255606000 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C1517945 (UMLS CUI 2011AA)
The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
Item
The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0085826 (UMLS CUI 2011AA)
372560006 (SNOMED CT 2011_0131)
C0003280 (UMLS CUI 2011AA)
372862008 (SNOMED CT 2011_0131)
C0028013 (UMLS CUI 2011AA)
33396006 (SNOMED CT 2011_0131)
MTHU003538 (LOINC Version 232)
C0040302 (UMLS CUI 2011AA)
1166006 (SNOMED CT 2011_0131)
MTHU014132 (LOINC Version 232)
C0039297 (UMLS CUI 2011AA)
45215009 (SNOMED CT 2011_0131)
The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
Item
The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0814423 (UMLS CUI 2011AA)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C1504374 (UMLS CUI 2011AA)
10063542 (MedDRA 14.1)
The subject has a history of bleeding diatheses or coagulopathy.
Item
The subject has a history of bleeding diatheses or coagulopathy.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
Item
The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
boolean
CL415222 (UMLS CUI 2011AA)
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
Item
The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
boolean
CL415222 (UMLS CUI 2011AA)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C0040046 (UMLS CUI 2011AA)
64156001 (SNOMED CT 2011_0131)
10043570 (MedDRA 14.1)
C0041948 (UMLS CUI 2011AA)
44730006 (SNOMED CT 2011_0131)
10046369 (MedDRA 14.1)
N19 (ICD-10-CM Version 2010)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
The subject is receiving dialysis or immunosuppressive therapy.
Item
The subject is receiving dialysis or immunosuppressive therapy.
boolean
C1514756 (UMLS CUI 2011AA)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
The subject is participating in an investigational drug or another investigational device study.
Item
The subject is participating in an investigational drug or another investigational device study.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0013230 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of < two years.
Item
The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of < two years.
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1511726 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
Item
The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
boolean
C0205231 (UMLS CUI 2011AA)
41118005 (SNOMED CT 2011_0131)
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1883719 (UMLS CUI 2011AA)
C0456642 (UMLS CUI 2011AA)
277312002 (SNOMED CT 2011_0131)
The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
Item
The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
boolean
C2986546 (UMLS CUI 2011AA)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0002940 (UMLS CUI 2011AA)
432119003 (SNOMED CT 2011_0131)
10002329 (MedDRA 14.1)
I72.9 (ICD-10-CM Version 2010)
442.9 (ICD-9-CM Version 2011)
C0005847 (UMLS CUI 2011AA)
59820001 (SNOMED CT 2011_0131)
MTHU020168 (LOINC Version 232)
C0441635 (UMLS CUI 2011AA)
264193005 (SNOMED CT 2011_0131)
The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
Item
The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
boolean
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C2700379 (UMLS CUI 2011AA)
C0678861 (UMLS CUI 2011AA)
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C1521721 (UMLS CUI 2011AA)
C0863745 (UMLS CUI 2011AA)
10052090 (MedDRA 14.1)
The subject is diagnosed with septicemia at the time of the study procedure.
Item
The subject is diagnosed with septicemia at the time of the study procedure.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0036690 (UMLS CUI 2011AA)
105592009 (SNOMED CT 2011_0131)
10040089 (MedDRA 14.1)
MTHU020833 (LOINC Version 232)
A41.9 (ICD-10-CM Version 2010)
038.9 (ICD-9-CM Version 2011)
E11560 (CTCAE 1105E)
C2348558 (UMLS CUI 2011AA)
Patients with a stent previously implanted into the target vessel.
Item
Patients with a stent previously implanted into the target vessel.
boolean
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
C0449618 (UMLS CUI 2011AA)
246325009 (SNOMED CT 2011_0131)
Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.
Item
Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.
boolean
C1511113 (UMLS CUI 2011AA)
C0302891 (UMLS CUI 2011AA)
263818007 (SNOMED CT 2011_0131)
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
C0205107 (UMLS CUI 2011AA)
40415009 (SNOMED CT 2011_0131)
C1278953 (UMLS CUI 2011AA)
181350008 (SNOMED CT 2011_0131)
C1706086 (UMLS CUI 2011AA)
C0015385 (UMLS CUI 2011AA)
66019005 (SNOMED CT 2011_0131)
MTHU001429 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL425202 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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