age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
Item
Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
boolean
C0449450 (UMLS CUI 2011AA)
246105001 (SNOMED CT 2011_0131)
C0020887 (UMLS CUI 2011AA)
10293006 (SNOMED CT 2011_0131)
MTHU011999 (LOINC Version 232)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1261287 (UMLS CUI 2011AA)
CL354751 (UMLS CUI 2011AA)
26036001 (SNOMED CT 2011_0131)
10029990 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0814634 (UMLS CUI 2011AA)
CL371838 (UMLS CUI 2011AA)
Patient presenting a score from 2 to 5 following Rutherford classification
Item
Patient presenting a score from 2 to 5 following Rutherford classification
boolean
C0449450 (UMLS CUI 2011AA)
246105001 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0332282 (UMLS CUI 2011AA)
255260001 (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 specified times for the duration of the study
Item
Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
boolean
C1522577 (UMLS CUI 2011AA)
Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Item
Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
boolean
C0021430 (UMLS CUI 2011AA)
Patient is eligible for treatment with the Misago (Terumo)
Item
Patient is eligible for treatment with the Misago (Terumo)
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:
Item
The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:
boolean
C1521840 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
Type A lesions
Item
Type A lesions
boolean
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
Unilateral or bilateral stenoses of the Common Iliac Artery
Item
Unilateral or bilateral stenoses of the Common Iliac Artery
boolean
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0340572 (UMLS CUI 2011AA)
233967001 (SNOMED CT 2011_0131)
Unilateral or bilateral single short (<=3 cm) stenosis of the External Iliac Artery
Item
Unilateral or bilateral single short (<=3 cm) stenosis of the External Iliac Artery
boolean
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1806781 (UMLS CUI 2011AA)
367450005 (SNOMED CT 2011_0131)
C0340573 (UMLS CUI 2011AA)
233968006 (SNOMED CT 2011_0131)
Type B lesions
Item
Type B lesions
boolean
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
Unilateral Common Iliac Artery occlusion
Item
Unilateral Common Iliac Artery occlusion
boolean
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0730201 (UMLS CUI 2011AA)
312825008 (SNOMED CT 2011_0131)
Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
Item
Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C1261287 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0226398 (UMLS CUI 2011AA)
113269004 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0439792 (UMLS CUI 2011AA)
260858005 (SNOMED CT 2011_0131)
C0447105 (UMLS CUI 2011AA)
181347005 (SNOMED CT 2011_0131)
Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
Item
Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
boolean
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0730202 (UMLS CUI 2011AA)
312826009 (SNOMED CT 2011_0131)
C0205429 (UMLS CUI 2011AA)
49907008 (SNOMED CT 2011_0131)
C0226364 (UMLS CUI 2011AA)
90024005 (SNOMED CT 2011_0131)
MTHU012057 (LOINC Version 232)
C1261084 (UMLS CUI 2011AA)
73634005 (SNOMED CT 2011_0131)
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
Item
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
boolean
C1521840 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
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)
C0181089 (UMLS CUI 2011AA)
129462001 (SNOMED CT 2011_0131)
C0947647 (UMLS CUI 2011AA)
19207007 (SNOMED CT 2011_0131)
10062053 (MedDRA 14.1)
There is angiographic evidence of a patent Common an Deep Femoral Artery
Item
There is angiographic evidence of a patent Common an Deep Femoral Artery
boolean
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0447105 (UMLS CUI 2011AA)
181347005 (SNOMED CT 2011_0131)
C0226455 (UMLS CUI 2011AA)
31677005 (SNOMED CT 2011_0131)
The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:
Item
The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:
boolean
C1521840 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C0003483 (UMLS CUI 2011AA)
15825003 (SNOMED CT 2011_0131)
MTHU003021 (LOINC Version 232)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Short (<=3 cm) stenosis of infrarenal aorta
Item
Short (<=3 cm) stenosis of infrarenal aorta
boolean
C1806781 (UMLS CUI 2011AA)
367450005 (SNOMED CT 2011_0131)
C1261287 (UMLS CUI 2011AA)
C0226025 (UMLS CUI 2011AA)
28205006 (SNOMED CT 2011_0131)
The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:
Item
The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:
boolean
C1521840 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
C0439107 (UMLS CUI 2011AA)
421450004 (SNOMED CT 2011_0131)
C0003483 (UMLS CUI 2011AA)
15825003 (SNOMED CT 2011_0131)
MTHU003021 (LOINC Version 232)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Presence of aneurysm at the level of the iliac arteries
Item
Presence of aneurysm at the level of the iliac arteries
boolean
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)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0020887 (UMLS CUI 2011AA)
10293006 (SNOMED CT 2011_0131)
MTHU011999 (LOINC Version 232)
Previously implanted stent(s) at the same lesion site
Item
Previously implanted stent(s) at the same lesion site
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
Reference segment diameter is not suitable for available stent design
Item
Reference segment diameter is not suitable for available stent design
boolean
C1706462 (UMLS CUI 2011AA)
C0441635 (UMLS CUI 2011AA)
264193005 (SNOMED CT 2011_0131)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C1548788 (UMLS CUI 2011AA)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
C1707689 (UMLS CUI 2011AA)
Untreatable lesion located at the distal outflow arteries
Item
Untreatable lesion located at the distal outflow arteries
boolean
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0205108 (UMLS CUI 2011AA)
46053002 (SNOMED CT 2011_0131)
C0205116 (UMLS CUI 2011AA)
33843005 (SNOMED CT 2011_0131)
C0003842 (UMLS CUI 2011AA)
51114001 (SNOMED CT 2011_0131)
MTHU020265 (LOINC Version 232)
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
Item
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
boolean
C1523987 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0162513 (UMLS CUI 2011AA)
6832004 (SNOMED CT 2011_0131)
10063025 (MedDRA 14.1)
MTHU011877 (LOINC Version 232)
CL382175 (UMLS CUI 2011AA)
CL382917 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
Patients refusing treatment
Item
Refusal of treatment by patient
boolean
C0040809 (UMLS CUI 2011AA)
105480006 (SNOMED CT 2011_0131)
10056407 (MedDRA 14.1)
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
Item
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
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 of the proposed lesion site
Item
Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
boolean
C0205322 (UMLS CUI 2011AA)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0087086 (UMLS CUI 2011AA)
396339007 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0225997 (UMLS CUI 2011AA)
67170007 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
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)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (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 a history of prior life-threatening contrast medium reaction
Item
Patients with a history of prior life-threatening contrast medium reaction
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2826244 (UMLS CUI 2011AA)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
C0443286 (UMLS CUI 2011AA)
263851003 (SNOMED CT 2011_0131)
MTHU014636 (LOINC Version 232)
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 < twelve months
Item
Life expectancy of < twelve months
boolean
C0023671 (UMLS CUI 2011AA)
Any planned surgical intervention/procedure within 30 days of the study procedure
Item
Any planned surgical intervention/procedure within 30 days of 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)
Any patient considered to be hemodynamically unstable at onset of procedure
Item
Any patient considered to be hemodynamically unstable at onset of procedure
boolean
C0948268 (UMLS CUI 2011AA)
422773005 (SNOMED CT 2011_0131)
10052076 (MedDRA 14.1)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C2700391 (UMLS CUI 2011AA)
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Item
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
boolean
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)