ID

5090

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01154751

Link

http://clinicaltrials.gov/show/NCT01154751

Stichworte

Versionen (2)
  1. 06.12.13 06.12.13 - Martin Dugas
  2. 17.04.14 17.04.14 - Julian Varghese
Hochgeladen am

17. April 2014

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT01154751 Superficial Femoral Artery Stenosis

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
Beschreibung

Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Rutherford-Becker classification 2 through 5 only
Beschreibung

Rutherford-Becker classification 2 through 5 only

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
Patient is at least 18 years of age and of legal age of consent.
Beschreibung

Patient is at least 18 years of age and of legal age of consent.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
Patient must be willing to participate in the registry for at least 5 years.
Beschreibung

Patient must be willing to participate in the registry for at least 5 years.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2348568
Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion >= 1 cm from origin of another stent. Additional lesions may be present, but there is only one target lesion.
Beschreibung

Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion >= 1 cm from origin of another stent. Additional lesions may be present, but there is only one target lesion.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1515568
UMLS CUI 2011AA
C0333186
SNOMED CT 2011_0131
43026009
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
UMLS CUI 2011AA
C1278953
SNOMED CT 2011_0131
181350008
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0038257
SNOMED CT 2011_0131
65818007
All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
Beschreibung

All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
CL384716
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0226455
SNOMED CT 2011_0131
31677005
All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
Beschreibung

All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1278953
SNOMED CT 2011_0131
181350008
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C0450429
SNOMED CT 2011_0131
246267002
UMLS CUI 2011AA
C0443204
SNOMED CT 2011_0131
263741009
UMLS CUI 2011AA
C1269020
SNOMED CT 2011_0131
181357006
UMLS CUI 2011AA
C0447111
SNOMED CT 2011_0131
244337009
Target lesion length 1-20 cm (visual estimate)
Beschreibung

Target lesion length 1-20 cm (visual estimate)

Datentyp

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
Target lesion stenosis >=50% (visual estimate)
Beschreibung

Target lesion stenosis >=50% (visual estimate)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C1261287
UMLS CUI 2011AA
C0444684
SNOMED CT 2011_0131
258083009
Popliteal artery patent if the lesion is in the SFA
Beschreibung

Popliteal artery patent if the lesion is in the SFA

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1278953
SNOMED CT 2011_0131
181350008
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
SFA patent if the lesion is in the popliteal artery
Beschreibung

SFA patent if the lesion is in the popliteal artery

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0447106
SNOMED CT 2011_0131
181349008
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1278953
SNOMED CT 2011_0131
181350008
At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
Beschreibung

At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
CL407133
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0447110
SNOMED CT 2011_0131
244336000
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
Beschreibung

Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0272285
SNOMED CT 2011_0131
73397007
MedDRA 14.1
10062506
UMLS CUI 2011AA
C0348016
SNOMED CT 2011_0131
255560000
UMLS CUI 2011AA
C0256103
SNOMED CT 2011_0131
37411004
UMLS CUI 2011AA
C0633084
SNOMED CT 2011_0131
412354008
UMLS CUI 2011AA
C0733420
SNOMED CT 2011_0131
412521005
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0036667
Patient is participating in a clinical study that could confound results
Beschreibung

Patient is participating in a clinical study that could confound results

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
Beschreibung

Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
Target lesion length > 20 cm
Beschreibung

Target lesion length > 20 cm

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2986546
UMLS CUI 2011AA
C1444754
SNOMED CT 2011_0131
410668003
LOINC Version 232
MTHU003498
Instent restenotic / reoccluded target lesion
Beschreibung

Instent restenotic / reoccluded target lesion

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1739098
MedDRA 14.1
10066052
UMLS CUI 2011AA
CL356003
UMLS CUI 2011AA
C2986546
Acute (<= 4 weeks) thrombotic occlusion
Beschreibung

Acute (<= 4 weeks) thrombotic occlusion

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C2883038
ICD-10-CM Version 2010
I74
Untreated ipsilateral pelvic stenosis
Beschreibung

Untreated ipsilateral pelvic stenosis

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0441989
SNOMED CT 2011_0131
255208005
UMLS CUI 2011AA
C0030797
SNOMED CT 2011_0131
12921003
LOINC Version 232
MTHU001438
UMLS CUI 2011AA
C1261287
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
Item
Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
boolean
C0021430 (UMLS CUI 2011AA)
Rutherford-Becker classification 2 through 5 only
Item
Rutherford-Becker classification 2 through 5 only
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
Patient is at least 18 years of age and of legal age of consent.
Item
Patient is at least 18 years of age and of legal age of consent.
boolean
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
Patient must be willing to participate in the registry for at least 5 years.
Item
Patient must be willing to participate in the registry for at least 5 years.
boolean
C2348568 (UMLS CUI 2011AA)
Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion >= 1 cm from origin of another stent. Additional lesions may be present, but there is only one target lesion.
Item
Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion >= 1 cm from origin of another stent. Additional lesions may be present, but there is only one target lesion.
boolean
C2986546 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1515568 (UMLS CUI 2011AA)
C0333186 (UMLS CUI 2011AA)
43026009 (SNOMED CT 2011_0131)
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
C1278953 (UMLS CUI 2011AA)
181350008 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL414705 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0038257 (UMLS CUI 2011AA)
65818007 (SNOMED CT 2011_0131)
All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
Item
All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
boolean
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
C2986546 (UMLS CUI 2011AA)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
CL384716 (UMLS CUI 2011AA)
CL414705 (UMLS CUI 2011AA)
C0226455 (UMLS CUI 2011AA)
31677005 (SNOMED CT 2011_0131)
All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
Item
All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
boolean
C1278953 (UMLS CUI 2011AA)
181350008 (SNOMED CT 2011_0131)
C2986546 (UMLS CUI 2011AA)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0443204 (UMLS CUI 2011AA)
263741009 (SNOMED CT 2011_0131)
C1269020 (UMLS CUI 2011AA)
181357006 (SNOMED CT 2011_0131)
C0447111 (UMLS CUI 2011AA)
244337009 (SNOMED CT 2011_0131)
Target lesion length 1-20 cm (visual estimate)
Item
Target lesion length 1-20 cm (visual estimate)
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)
Target lesion stenosis >=50% (visual estimate)
Item
Target lesion stenosis >=50% (visual estimate)
boolean
C2986546 (UMLS CUI 2011AA)
C1261287 (UMLS CUI 2011AA)
C0444684 (UMLS CUI 2011AA)
258083009 (SNOMED CT 2011_0131)
Popliteal artery patent if the lesion is in the SFA
Item
Popliteal artery patent if the lesion is in the SFA
boolean
C1278953 (UMLS CUI 2011AA)
181350008 (SNOMED CT 2011_0131)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
SFA patent if the lesion is in the popliteal artery
Item
SFA patent if the lesion is in the popliteal artery
boolean
C0447106 (UMLS CUI 2011AA)
181349008 (SNOMED CT 2011_0131)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1278953 (UMLS CUI 2011AA)
181350008 (SNOMED CT 2011_0131)
At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
Item
At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
CL407133 (UMLS CUI 2011AA)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0447110 (UMLS CUI 2011AA)
244336000 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
Item
Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
boolean
C0272285 (UMLS CUI 2011AA)
73397007 (SNOMED CT 2011_0131)
10062506 (MedDRA 14.1)
C0348016 (UMLS CUI 2011AA)
255560000 (SNOMED CT 2011_0131)
C0256103 (UMLS CUI 2011AA)
37411004 (SNOMED CT 2011_0131)
C0633084 (UMLS CUI 2011AA)
412354008 (SNOMED CT 2011_0131)
C0733420 (UMLS CUI 2011AA)
412521005 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0036667 (UMLS CUI 2011AA)
Patient is participating in a clinical study that could confound results
Item
Patient is participating in a clinical study that could confound results
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
Item
Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Target lesion length > 20 cm
Item
Target lesion length > 20 cm
boolean
C2986546 (UMLS CUI 2011AA)
C1444754 (UMLS CUI 2011AA)
410668003 (SNOMED CT 2011_0131)
MTHU003498 (LOINC Version 232)
Instent restenotic / reoccluded target lesion
Item
Instent restenotic / reoccluded target lesion
boolean
C1739098 (UMLS CUI 2011AA)
10066052 (MedDRA 14.1)
CL356003 (UMLS CUI 2011AA)
C2986546 (UMLS CUI 2011AA)
Acute (<= 4 weeks) thrombotic occlusion
Item
Acute (<= 4 weeks) thrombotic occlusion
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C2883038 (UMLS CUI 2011AA)
I74 (ICD-10-CM Version 2010)
Untreated ipsilateral pelvic stenosis
Item
Untreated ipsilateral pelvic stenosis
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0441989 (UMLS CUI 2011AA)
255208005 (SNOMED CT 2011_0131)
C0030797 (UMLS CUI 2011AA)
12921003 (SNOMED CT 2011_0131)
MTHU001438 (LOINC Version 232)
C1261287 (UMLS CUI 2011AA)
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