ID

44589

Description

ODM derived from http://clinicaltrials.gov/show/NCT01016275

Link

http://clinicaltrials.gov/show/NCT01016275

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01016275 Iliac Lesions

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0449450
SNOMED CT 2011_0131
246105001
UMLS CUI 2011AA
C0020887
SNOMED CT 2011_0131
10293006
LOINC Version 232
MTHU011999
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
CL354751
SNOMED CT 2011_0131
26036001
MedDRA 14.1
10029990
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
CL371838
Patient presenting a score from 2 to 5 following Rutherford classification
Description

Patient presenting a score from 2 to 5 following Rutherford classification

Data type

boolean

Alias
UMLS CUI 2011AA
C0449450
SNOMED CT 2011_0131
246105001
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
Description

Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1522577
Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Description

Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Patient is eligible for treatment with the Misago (Terumo)
Description

Patient is eligible for treatment with the Misago (Terumo)

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:
Description

The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:

Data type

boolean

Alias
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
Type A lesions
Description

Type A lesions

Data type

boolean

Alias
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
Unilateral or bilateral stenoses of the Common Iliac Artery
Description

Unilateral or bilateral stenoses of the Common Iliac Artery

Data type

boolean

Alias
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C0340572
SNOMED CT 2011_0131
233967001
Unilateral or bilateral single short (<=3 cm) stenosis of the External Iliac Artery
Description

Unilateral or bilateral single short (<=3 cm) stenosis of the External Iliac Artery

Data type

boolean

Alias
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1806781
SNOMED CT 2011_0131
367450005
UMLS CUI 2011AA
C0340573
SNOMED CT 2011_0131
233968006
Type B lesions
Description

Type B lesions

Data type

boolean

Alias
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
Unilateral Common Iliac Artery occlusion
Description

Unilateral Common Iliac Artery occlusion

Data type

boolean

Alias
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0730201
SNOMED CT 2011_0131
312825008
Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
Description

Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery

Data type

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0226398
SNOMED CT 2011_0131
113269004
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0439792
SNOMED CT 2011_0131
260858005
UMLS CUI 2011AA
C0447105
SNOMED CT 2011_0131
181347005
Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
Description

Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery

Data type

boolean

Alias
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0730202
SNOMED CT 2011_0131
312826009
UMLS CUI 2011AA
C0205429
SNOMED CT 2011_0131
49907008
UMLS CUI 2011AA
C0226364
SNOMED CT 2011_0131
90024005
LOINC Version 232
MTHU012057
UMLS CUI 2011AA
C1261084
SNOMED CT 2011_0131
73634005
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
Description

The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation

Data type

boolean

Alias
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
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
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
C0181089
SNOMED CT 2011_0131
129462001
UMLS CUI 2011AA
C0947647
SNOMED CT 2011_0131
19207007
MedDRA 14.1
10062053
There is angiographic evidence of a patent Common an Deep Femoral Artery
Description

There is angiographic evidence of a patent Common an Deep Femoral Artery

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
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0447105
SNOMED CT 2011_0131
181347005
UMLS CUI 2011AA
C0226455
SNOMED CT 2011_0131
31677005
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:
Description

The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:

Data type

boolean

Alias
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
UMLS CUI 2011AA
C0003483
SNOMED CT 2011_0131
15825003
LOINC Version 232
MTHU003021
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Short (<=3 cm) stenosis of infrarenal aorta
Description

Short (<=3 cm) stenosis of infrarenal aorta

Data type

boolean

Alias
UMLS CUI 2011AA
C1806781
SNOMED CT 2011_0131
367450005
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
C0226025
SNOMED CT 2011_0131
28205006
The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:
Description

The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:

Data type

boolean

Alias
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C0439106
SNOMED CT 2011_0131
257962003
UMLS CUI 2011AA
C0439107
SNOMED CT 2011_0131
421450004
UMLS CUI 2011AA
C0003483
SNOMED CT 2011_0131
15825003
LOINC Version 232
MTHU003021
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Presence of aneurysm at the level of the iliac arteries
Description

Presence of aneurysm at the level of the iliac arteries

Data type

boolean

Alias
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
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0020887
SNOMED CT 2011_0131
10293006
LOINC Version 232
MTHU011999
Previously implanted stent(s) at the same lesion site
Description

Previously implanted stent(s) at the same lesion site

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
UMLS CUI 2011AA
C0445247
SNOMED CT 2011_0131
262126009
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0205145
SNOMED CT 2011_0131
10546003
LOINC Version 232
MTHU014632
Reference segment diameter is not suitable for available stent design
Description

Reference segment diameter is not suitable for available stent design

Data type

boolean

Alias
UMLS CUI 2011AA
C1706462
UMLS CUI 2011AA
C0441635
SNOMED CT 2011_0131
264193005
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
UMLS CUI 2011AA
C1707689
Untreatable lesion located at the distal outflow arteries
Description

Untreatable lesion located at the distal outflow arteries

Data type

boolean

Alias
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C0205108
SNOMED CT 2011_0131
46053002
UMLS CUI 2011AA
C0205116
SNOMED CT 2011_0131
33843005
UMLS CUI 2011AA
C0003842
SNOMED CT 2011_0131
51114001
LOINC Version 232
MTHU020265
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
Description

Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C1523987
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0162513
SNOMED CT 2011_0131
6832004
MedDRA 14.1
10063025
LOINC Version 232
MTHU011877
UMLS CUI 2011AA
CL382175
UMLS CUI 2011AA
CL382917
UMLS CUI 2011AA
C0034619
Refusal of treatment by patient
Description

Patients refusing treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0040809
SNOMED CT 2011_0131
105480006
MedDRA 14.1
10056407
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
Description

Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated

Data type

boolean

Alias
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C1096021
MedDRA 14.1
10053460
UMLS CUI 2011AA
C0003280
SNOMED CT 2011_0131
372862008
UMLS CUI 2011AA
C0016018
SNOMED CT 2011_0131
303960004
Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
Description

Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site

Data type

boolean

Alias
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0087086
SNOMED CT 2011_0131
396339007
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0225997
SNOMED CT 2011_0131
67170007
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0205145
SNOMED CT 2011_0131
10546003
LOINC Version 232
MTHU014632
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Description

Perforation at the angioplasty site evidenced by extravasation of contrast medium

Data type

boolean

Alias
UMLS CUI 2011AA
C0549099
SNOMED CT 2011_0131
36191001
UMLS CUI 2011AA
C0162577
SNOMED CT 2011_0131
418285008
MedDRA 14.1
10002475
LOINC Version 232
MTHU011020
UMLS CUI 2011AA
C0205145
SNOMED CT 2011_0131
10546003
LOINC Version 232
MTHU014632
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0015376
SNOMED CT 2011_0131
76676007
MedDRA 14.1
10015866
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
Patients with a history of prior life-threatening contrast medium reaction
Description

Patients with a history of prior life-threatening contrast medium reaction

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
UMLS CUI 2011AA
C0443286
SNOMED CT 2011_0131
263851003
LOINC Version 232
MTHU014636
Patients with known hypersensitivity to nickel-titanium
Description

Patients with known hypersensitivity to nickel-titanium

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0076736
SNOMED CT 2011_0131
261250004
Patients with uncorrected bleeding disorders
Description

Patients with uncorrected bleeding disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205202
SNOMED CT 2011_0131
33714007
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Description

Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Life expectancy of < twelve months
Description

Life expectancy of < twelve months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Any planned surgical intervention/procedure within 30 days of the study procedure
Description

Any planned surgical intervention/procedure within 30 days of the study procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
Any patient considered to be hemodynamically unstable at onset of procedure
Description

Any patient considered to be hemodynamically unstable at onset of procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C0948268
SNOMED CT 2011_0131
422773005
MedDRA 14.1
10052076
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C2700391
Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
Description

Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Back to the top of the page

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 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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial