ID
5095
Description
ODM derived from http://clinicaltrials.gov/show/NCT01179984
Lien
http://clinicaltrials.gov/show/NCT01179984
Mots-clés
Versions (3)
- 06/12/2013 06/12/2013 - Martin Dugas
- 19/04/2014 19/04/2014 - Julian Varghese
- 27/09/2021 27/09/2021 -
Téléchargé le
19 avril 2014
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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Eligibility NCT01179984 Peripheral Vascular Disease
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
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.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0021430
Description
The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C2945599
- SNOMED CT 2011_0131
- 255604002
- UMLS CUI 2011AA
- C0311395
- SNOMED CT 2011_0131
- 275520000
- MedDRA 14.1
- 10009240
- UMLS CUI 2011AA
- C1142264
- MedDRA 14.1
- 10058069
- UMLS CUI 2011AA
- C0205165
- SNOMED CT 2011_0131
- 255606000
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0040300
- SNOMED CT 2011_0131
- 85756007
- UMLS CUI 2011AA
- C1517945
Description
The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0085826
- SNOMED CT 2011_0131
- 372560006
- UMLS CUI 2011AA
- C0003280
- SNOMED CT 2011_0131
- 372862008
- UMLS CUI 2011AA
- C0028013
- SNOMED CT 2011_0131
- 33396006
- LOINC Version 232
- MTHU003538
- UMLS CUI 2011AA
- C0040302
- SNOMED CT 2011_0131
- 1166006
- LOINC Version 232
- MTHU014132
- UMLS CUI 2011AA
- C0039297
- SNOMED CT 2011_0131
- 45215009
Description
The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0009924
- SNOMED CT 2011_0131
- 385420005
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0814423
- UMLS CUI 2011AA
- C0149783
- SNOMED CT 2011_0131
- 297279009
- MedDRA 14.1
- 10062117
- UMLS CUI 2011AA
- C1504374
- MedDRA 14.1
- 10063542
Description
The subject has a history of bleeding diatheses or coagulopathy.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1458140
- SNOMED CT 2011_0131
- 248250000
- MedDRA 14.1
- 10005134
- UMLS CUI 2011AA
- C0005779
- SNOMED CT 2011_0131
- 64779008
- MedDRA 14.1
- 10009802
- ICD-10-CM Version 2010
- D68.9
Description
The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- C0010294
- SNOMED CT 2011_0131
- 15373003
- MedDRA 14.1
- 10011358
- LOINC Version 232
- 38483-4
Description
The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C1306571
- SNOMED CT 2011_0131
- 59927004
- MedDRA 14.1
- 10056542
- UMLS CUI 2011AA
- C0040046
- SNOMED CT 2011_0131
- 64156001
- MedDRA 14.1
- 10043570
- UMLS CUI 2011AA
- C0041948
- SNOMED CT 2011_0131
- 44730006
- MedDRA 14.1
- 10046369
- ICD-10-CM Version 2010
- N19
- UMLS CUI 2011AA
- C0024141
- SNOMED CT 2011_0131
- 55464009
- MedDRA 14.1
- 10042945
- ICD-10-CM Version 2010
- M32.9
- ICD-9-CM Version 2011
- 710.0
- UMLS CUI 2011AA
- C0149871
- SNOMED CT 2011_0131
- 128053003
- MedDRA 14.1
- 10051055
- ICD-10-CM Version 2010
- I82.40
Description
The subject is receiving dialysis or immunosuppressive therapy.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0011946
- SNOMED CT 2011_0131
- 108241001
- MedDRA 14.1
- 10061105
- UMLS CUI 2011AA
- C0021079
- SNOMED CT 2011_0131
- 86553008
Description
The subject is participating in an investigational drug or another investigational device study.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C2346570
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
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.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0231347
- SNOMED CT 2011_0131
- 45704003
- UMLS CUI 2011AA
- C2348563
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C1511726
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0332281
- SNOMED CT 2011_0131
- 47429007
- UMLS CUI 2011AA
- C0439801
- SNOMED CT 2011_0131
- 255469002
- UMLS CUI 2011AA
- C0023671
- LOINC Version 232
- LP75025-4
Description
The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0205231
- SNOMED CT 2011_0131
- 41118005
- UMLS CUI 2011AA
- C0085096
- SNOMED CT 2011_0131
- 400047006
- MedDRA 14.1
- 10034636
- LOINC Version 232
- MTHU020791
- ICD-10-CM Version 2010
- I73.9
- ICD-9-CM Version 2011
- 443.9
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C1883719
- UMLS CUI 2011AA
- C0456642
- SNOMED CT 2011_0131
- 277312002
Description
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).
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C2986546
- UMLS CUI 2011AA
- C0450429
- SNOMED CT 2011_0131
- 246267002
- UMLS CUI 2011AA
- C0332281
- SNOMED CT 2011_0131
- 47429007
- 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
- C0005847
- SNOMED CT 2011_0131
- 59820001
- LOINC Version 232
- MTHU020168
- UMLS CUI 2011AA
- C0441635
- SNOMED CT 2011_0131
- 264193005
Description
The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
Type de données
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
- C2700379
- UMLS CUI 2011AA
- C0678861
- UMLS CUI 2011AA
- C0205412
- SNOMED CT 2011_0131
- 71978007
- UMLS CUI 2011AA
- C1521721
- UMLS CUI 2011AA
- C0863745
- MedDRA 14.1
- 10052090
Description
The subject is diagnosed with septicemia at the time of the study procedure.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0036690
- SNOMED CT 2011_0131
- 105592009
- MedDRA 14.1
- 10040089
- LOINC Version 232
- MTHU020833
- ICD-10-CM Version 2010
- A41.9
- ICD-9-CM Version 2011
- 038.9
- CTCAE 1105E
- E11560
- UMLS CUI 2011AA
- C2348558
Description
Patients with a stent previously implanted into the target vessel.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0038257
- SNOMED CT 2011_0131
- 65818007
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0021102
- SNOMED CT 2011_0131
- 40388003
- UMLS CUI 2011AA
- C0449618
- SNOMED CT 2011_0131
- 246325009
Description
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.
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1511113
- UMLS CUI 2011AA
- C0302891
- SNOMED CT 2011_0131
- 263818007
- UMLS CUI 2011AA
- C0447106
- SNOMED CT 2011_0131
- 181349008
- UMLS CUI 2011AA
- C0205107
- SNOMED CT 2011_0131
- 40415009
- UMLS CUI 2011AA
- C1278953
- SNOMED CT 2011_0131
- 181350008
- UMLS CUI 2011AA
- C1706086
- UMLS CUI 2011AA
- C0015385
- SNOMED CT 2011_0131
- 66019005
- LOINC Version 232
- MTHU001429
- UMLS CUI 2011AA
- C1550543
- HL7 V3 2006_05
- FLFS
- UMLS CUI 2011AA
- CL425202
- UMLS CUI 2011AA
- CL425201
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C0039798
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
C1522577 (UMLS CUI 2011AA)
C2700391 (UMLS CUI 2011AA)
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65818007 (SNOMED CT 2011_0131)
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C0205447 (UMLS CUI 2011AA)
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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)
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)
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)
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)
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392521001 (SNOMED CT 2011_0131)
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248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
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64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
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10038474 (MedDRA 14.1)
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15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
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10043570 (MedDRA 14.1)
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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)
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
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86553008 (SNOMED CT 2011_0131)
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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)
MEDCCAT (HL7 V3 2006_05)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
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78235001 (SNOMED CT 2011_0131)
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41118005 (SNOMED CT 2011_0131)
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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)
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C0456642 (UMLS CUI 2011AA)
277312002 (SNOMED CT 2011_0131)
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)
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)
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)
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)
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)