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
C0086287 (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)
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)