age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
Item
De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
boolean
C1515568 (UMLS CUI 2011AA)
C0333186 (UMLS CUI 2011AA)
43026009 (SNOMED CT 2011_0131)
C0854571 (UMLS CUI 2011AA)
10038563 (MedDRA 14.1)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C2721556 (UMLS CUI 2011AA)
10069344 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0814634 (UMLS CUI 2011AA)
C2936204 (UMLS CUI 2011AA)
Patient presenting with a score from 2 to 4 according to the Rutherford classification
Item
Patient presenting with a score from 2 to 4 according to the Rutherford classification
boolean
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
Item
Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1522577 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
Item
Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
Item
Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C2986546 (UMLS CUI 2011AA)
C0205203 (UMLS CUI 2011AA)
65145006 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0181089 (UMLS CUI 2011AA)
129462001 (SNOMED CT 2011_0131)
C0947647 (UMLS CUI 2011AA)
19207007 (SNOMED CT 2011_0131)
10062053 (MedDRA 14.1)
Patient is eligible for treatment with 4F compatible devices
Item
Patient is eligible for treatment with 4F compatible devices
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
Item
The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
boolean
C2986546 (UMLS CUI 2011AA)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0302891 (UMLS CUI 2011AA)
263818007 (SNOMED CT 2011_0131)
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
Item
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
boolean
C2986546 (UMLS CUI 2011AA)
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
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)
Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
Item
Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
boolean
C2986546 (UMLS CUI 2011AA)
C1444754 (UMLS CUI 2011AA)
410668003 (SNOMED CT 2011_0131)
MTHU003498 (LOINC Version 232)
C0444684 (UMLS CUI 2011AA)
258083009 (SNOMED CT 2011_0131)
C0814634 (UMLS CUI 2011AA)
C0439844 (UMLS CUI 2011AA)
255334000 (SNOMED CT 2011_0131)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
Target vessel diameter visually estimated is =4 mm and =6.5 mm
Item
Target vessel diameter visually estimated is =4 mm and =6.5 mm
boolean
C0449618 (UMLS CUI 2011AA)
246325009 (SNOMED CT 2011_0131)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0444684 (UMLS CUI 2011AA)
258083009 (SNOMED CT 2011_0131)
There is angiographic evidence of at least one-vessel-runoff to the foot
Item
There is angiographic evidence of at least one-vessel-runoff to the foot
boolean
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (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)
Presence of another stent in the target vessel that was placed during a previous procedure
Item
Presence of another stent in the target vessel that was placed during a previous procedure
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
C0449618 (UMLS CUI 2011AA)
246325009 (SNOMED CT 2011_0131)
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Item
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
boolean
C0854142 (UMLS CUI 2011AA)
10002910 (MedDRA 14.1)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0730206 (UMLS CUI 2011AA)
312829002 (SNOMED CT 2011_0131)
Previous bypass surgery in the same limb
Item
Previous bypass surgery in the same limb
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1536078 (UMLS CUI 2011AA)
10063919 (MedDRA 14.1)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C1280090 (UMLS CUI 2011AA)
243996003 (SNOMED CT 2011_0131)
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
Item
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
boolean
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C1096021 (UMLS CUI 2011AA)
10053460 (MedDRA 14.1)
C0003280 (UMLS CUI 2011AA)
372862008 (SNOMED CT 2011_0131)
C0016018 (UMLS CUI 2011AA)
303960004 (SNOMED CT 2011_0131)
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
Item
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
boolean
C0205322 (UMLS CUI 2011AA)
C0087086 (UMLS CUI 2011AA)
396339007 (SNOMED CT 2011_0131)
C0225997 (UMLS CUI 2011AA)
67170007 (SNOMED CT 2011_0131)
C2986546 (UMLS CUI 2011AA)
C1515974 (UMLS CUI 2011AA)
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Item
Perforation at the angioplasty site evidenced by extravasation of contrast medium
boolean
C0549099 (UMLS CUI 2011AA)
36191001 (SNOMED CT 2011_0131)
C0162577 (UMLS CUI 2011AA)
418285008 (SNOMED CT 2011_0131)
10002475 (MedDRA 14.1)
MTHU011020 (LOINC Version 232)
C1515974 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0015376 (UMLS CUI 2011AA)
76676007 (SNOMED CT 2011_0131)
10015866 (MedDRA 14.1)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
Patients with known hypersensitivity to nickel-titanium
Item
Patients with known hypersensitivity to nickel-titanium
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0076736 (UMLS CUI 2011AA)
261250004 (SNOMED CT 2011_0131)
Patients with uncorrected bleeding disorders
Item
Patients with uncorrected bleeding disorders
boolean
C1518422 (UMLS CUI 2011AA)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Item
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Life expectancy of < 12 months
Item
Life expectancy of < 12 months
boolean
C0023671 (UMLS CUI 2011AA)
Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
Item
Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
boolean
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0020887 (UMLS CUI 2011AA)
10293006 (SNOMED CT 2011_0131)
MTHU011999 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2986546 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C1261287 (UMLS CUI 2011AA)
Use of thrombectomy, atherectomy or laser devices during procedure
Item
Use of thrombectomy, atherectomy or laser devices during procedure
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0162578 (UMLS CUI 2011AA)
43810009 (SNOMED CT 2011_0131)
10043530 (MedDRA 14.1)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
C0522642 (UMLS CUI 2011AA)
102312002 (SNOMED CT 2011_0131)
C0023089 (UMLS CUI 2011AA)
122456005 (SNOMED CT 2011_0131)
Any planned surgical intervention/procedure 30 days after the study procedure
Item
Any planned surgical intervention/procedure 30 days after the study procedure
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0549433 (UMLS CUI 2011AA)
10048451 (MedDRA 14.1)
Any patient considered to be hemodynamically unstable at onset of procedure
Item
Any patient considered to be hemodynamically unstable at onset of procedure
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0948268 (UMLS CUI 2011AA)
422773005 (SNOMED CT 2011_0131)
10052076 (MedDRA 14.1)
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Item
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)