Eligibility NCT00442065 Abdominal Aortic Aneurysm

ODM derived from http://clinicaltrials.gov/show/NCT00442065

Eligibility

  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 19 Years
Item
age at least 19 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm.
Item
Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0162871 (UMLS CUI 2011AA)
233985008 (SNOMED CT 2011_0131)
10000054 (MedDRA 14.1)
C0549177 (UMLS CUI 2011AA)
255509001 (SNOMED CT 2011_0131)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C0013931 (UMLS CUI 2011AA)
122463005 (SNOMED CT 2011_0131)
10057335 (MedDRA 14.1)
MTHU011031 (LOINC Version 232)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0162871 (UMLS CUI 2011AA)
233985008 (SNOMED CT 2011_0131)
10000054 (MedDRA 14.1)
C0220844 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439200 (UMLS CUI 2011AA)
258673006 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0231448 (UMLS CUI 2011AA)
255536004 (SNOMED CT 2011_0131)
MTHU010348 (LOINC Version 232)
C1261084 (UMLS CUI 2011AA)
73634005 (SNOMED CT 2011_0131)
C2713497 (UMLS CUI 2011AA)
54002007 (SNOMED CT 2011_0131)
Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions.
Item
Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions.
boolean
C0205064 (UMLS CUI 2011AA)
261064006 (SNOMED CT 2011_0131)
CL384716 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C1524031 (UMLS CUI 2011AA)
C1444754 (UMLS CUI 2011AA)
410668003 (SNOMED CT 2011_0131)
MTHU003498 (LOINC Version 232)
C0205143 (UMLS CUI 2011AA)
1483009 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439534 (UMLS CUI 2011AA)
255506008 (SNOMED CT 2011_0131)
The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual).
Item
The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual).
boolean
C0020887 (UMLS CUI 2011AA)
10293006 (SNOMED CT 2011_0131)
MTHU011999 (LOINC Version 232)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0205108 (UMLS CUI 2011AA)
46053002 (SNOMED CT 2011_0131)
C1444754 (UMLS CUI 2011AA)
410668003 (SNOMED CT 2011_0131)
MTHU003498 (LOINC Version 232)
C0333076 (UMLS CUI 2011AA)
15690004 (SNOMED CT 2011_0131)
C1261084 (UMLS CUI 2011AA)
73634005 (SNOMED CT 2011_0131)
C0226398 (UMLS CUI 2011AA)
113269004 (SNOMED CT 2011_0131)
C0015801 (UMLS CUI 2011AA)
7657000 (SNOMED CT 2011_0131)
MTHU011981 (LOINC Version 232)
C0205251 (UMLS CUI 2011AA)
62482003 (SNOMED CT 2011_0131)
C0439536 (UMLS CUI 2011AA)
255508009 (SNOMED CT 2011_0131)
Patient provides written informed consent.
Item
Patient provides written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Patients >18 years who are suitable for endovascular repair.
Item
Patients >18 years who are suitable for endovascular repair.
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C2586001 (UMLS CUI 2011AA)
439529000 (SNOMED CT 2011_0131)
Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally.
Item
Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally.
boolean
C0424576 (UMLS CUI 2011AA)
102499006 (SNOMED CT 2011_0131)
C0005847 (UMLS CUI 2011AA)
59820001 (SNOMED CT 2011_0131)
MTHU020168 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0444454 (UMLS CUI 2011AA)
260507000 (SNOMED CT 2011_0131)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439200 (UMLS CUI 2011AA)
258673006 (SNOMED CT 2011_0131)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
Patient has a life expectancy longer than the duration of the study.
Item
Patient has a life expectancy longer than the duration of the study.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient has a ruptured aneurysm.
Item
Ruptured Aneurysm
boolean
C0162869 (UMLS CUI 2011AA)
22039006 (SNOMED CT 2011_0131)
10048380 (MedDRA 14.1)
Patient has insufficient length of proximal aneurysm neck (<15mm from aneurysm to lowest renal artery and <20 mm from the aneurysm to the SMA).
Item
Patient has insufficient length of proximal aneurysm neck (<15mm from aneurysm to lowest renal artery and <20 mm from the aneurysm to the SMA).
boolean
C0231180 (UMLS CUI 2011AA)
423437008 (SNOMED CT 2011_0131)
C1444754 (UMLS CUI 2011AA)
410668003 (SNOMED CT 2011_0131)
MTHU003498 (LOINC Version 232)
C0205107 (UMLS CUI 2011AA)
40415009 (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)
C0205064 (UMLS CUI 2011AA)
261064006 (SNOMED CT 2011_0131)
C1708760 (UMLS CUI 2011AA)
C0035065 (UMLS CUI 2011AA)
2841007 (SNOMED CT 2011_0131)
MTHU016747 (LOINC Version 232)
C0162861 (UMLS CUI 2011AA)
42258001 (SNOMED CT 2011_0131)
MTHU016956 (LOINC Version 232)
Aneurysm extends above renal arteries.
Item
Aneurysm extends above renal 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)
C0231449 (UMLS CUI 2011AA)
288467006 (SNOMED CT 2011_0131)
CL384738 (UMLS CUI 2011AA)
C0035065 (UMLS CUI 2011AA)
2841007 (SNOMED CT 2011_0131)
MTHU016747 (LOINC Version 232)
Proximal neck of aneurysm has significant loose thrombus associated with it, or significant circumferential calcifications.
Item
Proximal neck of aneurysm has significant loose thrombus associated with it, or significant circumferential calcifications.
boolean
C0205107 (UMLS CUI 2011AA)
40415009 (SNOMED CT 2011_0131)
C0205064 (UMLS CUI 2011AA)
261064006 (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)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205407 (UMLS CUI 2011AA)
78799005 (SNOMED CT 2011_0131)
C0087086 (UMLS CUI 2011AA)
396339007 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205113 (UMLS CUI 2011AA)
255593009 (SNOMED CT 2011_0131)
C1533591 (UMLS CUI 2011AA)
10012367 (MedDRA 14.1)
Pregnant or nursing patients.
Item
Pregnant or nursing patients.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Patient unfit for bail-out surgery and appropriate anaesthesia.
Item
Patient unfit for bail-out surgery and appropriate anaesthesia.
boolean
C1518422 (UMLS CUI 2011AA)
C0424576 (UMLS CUI 2011AA)
102499006 (SNOMED CT 2011_0131)
C0175673 (UMLS CUI 2011AA)
25876001 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0002903 (UMLS CUI 2011AA)
399097000 (SNOMED CT 2011_0131)
10002091 (MedDRA 14.1)
MTHU035920 (LOINC Version 232)
Patient with an acute or chronic aortic dissection or mycotic aneurysm (defined by localised asymmetric aneurysm sac).
Item
Patient with an acute or chronic aortic dissection or mycotic aneurysm (defined by localised asymmetric aneurysm sac).
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0340643 (UMLS CUI 2011AA)
308546005 (SNOMED CT 2011_0131)
10002895 (MedDRA 14.1)
I71.00 (ICD-10-CM Version 2010)
C0085808 (UMLS CUI 2011AA)
233991005 (SNOMED CT 2011_0131)
10028517 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
CL381523 (UMLS CUI 2011AA)
C2713497 (UMLS CUI 2011AA)
54002007 (SNOMED CT 2011_0131)
Patient has current non-localised infection.
Item
Patient has current non-localised infection.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Patient has known allergy to graft materials, Nitinol, or contrast media.
Item
Patient has known allergy to graft materials, Nitinol, or contrast media.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0181074 (UMLS CUI 2011AA)
246345001 (SNOMED CT 2011_0131)
MTHU020176 (LOINC Version 232)
C0068790 (UMLS CUI 2011AA)
C0009924 (UMLS CUI 2011AA)
385420005 (SNOMED CT 2011_0131)
Patient's where imaging is problematic. An example is an obese patient.
Item
Patient's where imaging is problematic. An example is an obese patient.
boolean
C0011923 (UMLS CUI 2011AA)
363679005 (SNOMED CT 2011_0131)
C0033213 (UMLS CUI 2011AA)
55607006 (SNOMED CT 2011_0131)
C1707959 (UMLS CUI 2011AA)
C0028754 (UMLS CUI 2011AA)
414916001 (SNOMED CT 2011_0131)
10029883 (MedDRA 14.1)
E66.0 (ICD-10-CM Version 2010)
278.00 (ICD-9-CM Version 2011)
E12361 (CTCAE 1105E)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Patient has co-morbidities that deny vascular access, including small / tortuous access vessels.
Item
Patient has co-morbidities that deny vascular access, including small / tortuous access vessels.
boolean
C0009488 (UMLS CUI 2011AA)
C2700401 (UMLS CUI 2011AA)
C0005847 (UMLS CUI 2011AA)
59820001 (SNOMED CT 2011_0131)
MTHU020168 (LOINC Version 232)
C0444454 (UMLS CUI 2011AA)
260507000 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0700321 (UMLS CUI 2011AA)
255507004 (SNOMED CT 2011_0131)
CL381564 (UMLS CUI 2011AA)
C0444454 (UMLS CUI 2011AA)
260507000 (SNOMED CT 2011_0131)
C0005847 (UMLS CUI 2011AA)
59820001 (SNOMED CT 2011_0131)
MTHU020168 (LOINC Version 232)

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