ID

43097

Description

ODM derived from http://clinicaltrials.gov/show/NCT01413139

Link

http://clinicaltrials.gov/show/NCT01413139

Keywords

Versions (3)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01413139 Peripheral Vascular Disease

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
Description

De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1515568
UMLS CUI 2011AA
C0333186
SNOMED CT 2011_0131
43026009
UMLS CUI 2011AA
C0854571
MedDRA 14.1
10038563
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C2721556
MedDRA 14.1
10069344
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
C2936204
Patient presenting with a score from 2 to 4 according to the Rutherford classification
Description

Patient presenting with a score from 2 to 4 according to the Rutherford classification

Data type

boolean

Alias
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
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 predefined time intervals times
Description

Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1522577
UMLS CUI 2011AA
C0220825
Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
Description

Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
Description

Prior to enrollment, the target lesion was crossed with standard guidewire manipulation

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0205203
SNOMED CT 2011_0131
65145006
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0181089
SNOMED CT 2011_0131
129462001
UMLS CUI 2011AA
C0947647
SNOMED CT 2011_0131
19207007
MedDRA 14.1
10062053
Patient is eligible for treatment with 4F compatible devices
Description

Patient is eligible for treatment with 4F compatible devices

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
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0699733
SNOMED CT 2011_0131
49062001
LOINC Version 232
MTHU020022
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C0302891
SNOMED CT 2011_0131
263818007
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
Description

The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion

Data type

boolean

Alias
UMLS CUI 2011AA
C2986546
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
Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
Description

Length of the target lesion is =20 cm by visual estimation and can be covered with one stent

Data type

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C1444754
SNOMED CT 2011_0131
410668003
LOINC Version 232
MTHU003498
UMLS CUI 2011AA
C0444684
SNOMED CT 2011_0131
258083009
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
C0439844
SNOMED CT 2011_0131
255334000
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
Target vessel diameter visually estimated is =4 mm and =6.5 mm
Description

Target vessel diameter visually estimated is =4 mm and =6.5 mm

Data type

boolean

Alias
UMLS CUI 2011AA
C0449618
SNOMED CT 2011_0131
246325009
UMLS CUI 2011AA
C1301886
SNOMED CT 2011_0131
81827009
LOINC Version 232
MTHU002654
UMLS CUI 2011AA
C0444684
SNOMED CT 2011_0131
258083009
There is angiographic evidence of at least one-vessel-runoff to the foot
Description

There is angiographic evidence of at least one-vessel-runoff to the foot

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
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
Exclusion Criteria
Description

Exclusion Criteria

Presence of another stent in the target vessel that was placed during a previous procedure
Description

Presence of another stent in the target vessel that was placed during a previous procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
UMLS CUI 2011AA
C0449618
SNOMED CT 2011_0131
246325009
Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
Description

Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0854142
MedDRA 14.1
10002910
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0730206
SNOMED CT 2011_0131
312829002
Previous bypass surgery in the same limb
Description

Previous bypass surgery in the same limb

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1536078
MedDRA 14.1
10063919
UMLS CUI 2011AA
C0445247
SNOMED CT 2011_0131
262126009
UMLS CUI 2011AA
C1280090
SNOMED CT 2011_0131
243996003
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
Description

Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics

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 at the target lesion site
Description

Patients who exhibit persistent acute intraluminal thrombus at the target lesion site

Data type

boolean

Alias
UMLS CUI 2011AA
C0205322
UMLS CUI 2011AA
C0087086
SNOMED CT 2011_0131
396339007
UMLS CUI 2011AA
C0225997
SNOMED CT 2011_0131
67170007
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C1515974
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
C1515974
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0015376
SNOMED CT 2011_0131
76676007
MedDRA 14.1
10015866
UMLS CUI 2011AA
C0009924
SNOMED CT 2011_0131
385420005
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 < 12 months
Description

Life expectancy of < 12 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
Description

Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%

Data type

boolean

Alias
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0020887
SNOMED CT 2011_0131
10293006
LOINC Version 232
MTHU011999
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1609982
SNOMED CT 2011_0131
65320000
UMLS CUI 2011AA
C1261287
Use of thrombectomy, atherectomy or laser devices during procedure
Description

Use of thrombectomy, atherectomy or laser devices during procedure

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0162578
SNOMED CT 2011_0131
43810009
MedDRA 14.1
10043530
UMLS CUI 2011AA
C0699733
SNOMED CT 2011_0131
49062001
LOINC Version 232
MTHU020022
UMLS CUI 2011AA
C0522642
SNOMED CT 2011_0131
102312002
UMLS CUI 2011AA
C0023089
SNOMED CT 2011_0131
122456005
Any planned surgical intervention/procedure 30 days after the study procedure
Description

Any planned surgical intervention/procedure 30 days after 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
UMLS CUI 2011AA
C0549433
MedDRA 14.1
10048451
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
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0948268
SNOMED CT 2011_0131
422773005
MedDRA 14.1
10052076
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
Description

Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
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
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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
age at least 18 Years
Item
age at least 18 Years
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)
Item Group
Exclusion Criteria
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)
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