ID

159

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01442636

Link

http://clinicaltrials.gov/show/NCT01442636

Stichworte

Versionen (2)
  1. 07.02.12 07.02.12 -
  2. 13.04.14 13.04.14 - Julian Varghese
Hochgeladen am

7. Februar 2012

DOI

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Eligibility NCT01442636 Peripheral Arterial Disease

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alter >18 Jahre
Beschreibung

Age

Datentyp

boolean

Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
Beschreibung

Rest pain or minor tissue loss

Datentyp

boolean

Patient is willing to comply with specified follow-up evaluations at the specified times
Beschreibung

Compliance

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Life-expectancy of at least 12 months
Beschreibung

Life-expectancy

Datentyp

boolean

Eligibility for treatment with XIENCE PRIME stent (Abbott Vascular)
Beschreibung

Eligibility

Datentyp

boolean

Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
Beschreibung

Male or non-pregnant female

Datentyp

boolean

Angiographic Inclusion Criteria
Beschreibung

Angiographic Inclusion Criteria

De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
Beschreibung

De novo lesion or restenotic lesion after PTA

Datentyp

boolean

Target lesion length minimally 30mm and maximally 100mm
Beschreibung

Target lesion length

Datentyp

boolean

Target vessel diameter >2.0mm and <3.5mm
Beschreibung

Target vessel diameter

Datentyp

boolean

Guidewire and delivery system successfully traversed lesion
Beschreibung

Guidewire and delivery system

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Patient refusing treatment
Beschreibung

Refusing treatment

Datentyp

boolean

Reference segment diameter not suitable for stent design
Beschreibung

Not suitable for stent design

Datentyp

boolean

Untreated flow-limiting inflow lesions
Beschreibung

Untreated lesions

Datentyp

boolean

Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
Beschreibung

Unsuccessful ipsilateral vascular procedure

Datentyp

boolean

Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
Beschreibung

Previous surgery in the target vessel

Datentyp

boolean

Aneurysm in the target vessel
Beschreibung

Aneurysm in the target vessel

Datentyp

boolean

Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
Beschreibung

Non-atherosclerotic disease resulting in occlusion

Datentyp

boolean

Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
Beschreibung

Medical comorbidities

Datentyp

boolean

Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
Beschreibung

Major distal amputation

Datentyp

boolean

Septicemia or bacteremia
Beschreibung

Septicemia or bacteremia

Datentyp

boolean

Any previously known coagulation disorder, including hypercoagulability
Beschreibung

Coagulation disorder

Datentyp

boolean

Contraindication to anticoagulation or antiplatelet therapy
Beschreibung

Contraindications

Datentyp

boolean

Known allergies to stent or stent components; Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
Beschreibung

Allergies

Datentyp

boolean

Hypersensitivity to heparin, including patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Beschreibung

Hypersensitivity to heparin

Datentyp

boolean

Currently participating in another clinical research trial
Beschreibung

Participating in another clinical research trial

Datentyp

boolean

Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
Beschreibung

Intra-arterial thrombus

Datentyp

boolean

Target lesion access not performed by transfemoral approach
Beschreibung

Target lesion access not performed by transfemoral approach

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Alter
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnose
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Ruheschmerz
Beschreibung

Rest pain

Datentyp

string

Alias
UMLS CUI
C0234253
SNOMED CT 2010_0731
52598005
MedDRA 13.1
10059073
Compliance
Beschreibung

Compliance

Datentyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Einverständniserklärung
Beschreibung

Informed Consent

Datentyp

string

Alias
UMLS CUI
C0021430
Life expectancy
Beschreibung

Life expectancy

Datentyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
Eligibility Determination
Beschreibung

Eligibility

Datentyp

string

Alias
UMLS CUI
C0013893
Gender
Beschreibung

Gender

Datentyp

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
Kontrazeption
Beschreibung

Contraception

Datentyp

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Serum pregnancy test (B-HCG)
Beschreibung

Serum pregnancy test

Datentyp

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
PTA
Beschreibung

PTA

Datentyp

string

Alias
UMLS CUI
C0883295
LOINC Version 232
MTHU012071
Vessel lumen diameter
Beschreibung

Vessel lumen diameter

Datentyp

string

Alias
UMLS CUI
C1301408
SNOMED CT 2010_0731
397413000
Stent, device
Beschreibung

Stent

Datentyp

string

Alias
UMLS CUI
C0038257
SNOMED CT 2010_0731
65818007
MedDRA 13.1
10002329
Therapeutic procedure
Beschreibung

Therapeutic procedure

Datentyp

string

Alias
UMLS CUI
C0087111
Aneurysma
Beschreibung

Aneurysm

Datentyp

string

Alias
UMLS CUI
C0002940
SNOMED CT 2010_0731
85659009
MedDRA 13.1
10061169
ICD-10-CM Version 2010
I72.9
ICD-9-CM Version 2011
442.9
Embolism
Beschreibung

Embolism

Datentyp

string

Alias
UMLS CUI
C0013922
SNOMED CT 2010_0731
414086009
MedDRA 13.1
10043540
Thromboangiitis Obliterans
Beschreibung

Buerger's disease

Datentyp

string

Alias
UMLS CUI
C0040021
SNOMED CT 2010_0731
52403007
MedDRA 13.1
10047115
ICD-10-CM Version 2010
I73.1
ICD-9-CM Version 2011
443.1
Vaskulitis
Beschreibung

Vasculitis

Datentyp

string

Alias
UMLS CUI
C0042384
SNOMED CT 2010_0731
31996006
MedDRA 13.1
10011078
CTCAE Version 4.03
E13837
Coronary Artery Disease
Beschreibung

CAD

Datentyp

string

Alias
UMLS CUI
C1956346
SNOMED CT 2010_0731
53741008
MedDRA 13.1
10007559
Congestive heart failure
Beschreibung

CHF

Datentyp

string

Alias
UMLS CUI
C0018802
SNOMED CT 2010_0731
42343007
MedDRA 13.1
10009033
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
COPD
Beschreibung

COPD

Datentyp

string

Alias
UMLS CUI
C0024117
SNOMED CT 2010_0731
13645005
MedDRA 13.1
10028997
ICD-10-CM Version 2010
J44.9
Malignant Neoplasms
Beschreibung

Malignant Neoplasms

Datentyp

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10012267
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C80
ICD-9-CM Version 2011
199
Demenz
Beschreibung

Dementia

Datentyp

string

Alias
UMLS CUI
C0497327
SNOMED CT 2010_0731
52448006
MedDRA 13.1
10061627
ICD-10-CM Version 2010
F03
ICD-9-CM Version 2011
290
Amputation
Beschreibung

Amputation

Datentyp

string

Alias
UMLS CUI
C0002688
SNOMED CT 2010_0731
81723002
MedDRA 13.1
10040082
ICD-9-CM Version 2011
84.91
Septikämie
Beschreibung

Septicemia

Datentyp

string

Alias
UMLS CUI
C0036690
SNOMED CT 2010_0731
105592009
MedDRA 13.1
10003997
LOINC Version 232
MTHU020833
ICD-10-CM Version 2010
A41.9
ICD-9-CM Version 2011
038.9
CTCAE Version 4.03
E11560
Bakteriämie
Beschreibung

Bacteremia

Datentyp

string

Alias
UMLS CUI
C0004610
SNOMED CT 2010_0731
5758002
MedDRA 13.1
10057396
ICD-10-CM Version 2010
R78.81
ICD-9-CM Version 2011
790.7
Thrombophilie
Beschreibung

Thrombophilia

Datentyp

string

Alias
UMLS CUI
C0398623
SNOMED CT 2010_0731
76612001
MedDRA 13.1
10010833
ICD-10-CM Version 2010
D68.59
Contraindication to medical treatment
Beschreibung

Contraindication to medical treatment

Datentyp

string

Alias
UMLS CUI
C0852648
Allergie
Beschreibung

Allergy

Datentyp

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Heparin
Beschreibung

Heparin

Datentyp

string

Alias
UMLS CUI
C0019134
SNOMED CT 2010_0731
372877000
MedDRA 13.1
10043554
LOINC Version 232
MTHU003766
Thrombocytopenia
Beschreibung

Thrombopenia

Datentyp

string

Alias
UMLS CUI
C0040034
SNOMED CT 2010_0731
302215000
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE Version 4.03
E12207
Thrombus
Beschreibung

Thrombus

Datentyp

string

Alias
UMLS CUI
C0087086
SNOMED CT 2010_0731
396339007
Atheroembolism
Beschreibung

Cholesterol Embolism

Datentyp

string

Alias
UMLS CUI
C0149649
SNOMED CT 2010_0731
10690002
ICD-10-CM Version 2010
I75
ICD-9-CM Version 2011
445
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C1516879
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
Alter >18 Jahre
boolean
Rest pain or minor tissue loss
Item
Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
boolean
Compliance
Item
Patient is willing to comply with specified follow-up evaluations at the specified times
boolean
Informed Consent
Item
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
boolean
Life-expectancy
Item
Life-expectancy of at least 12 months
boolean
Eligibility
Item
Eligibility for treatment with XIENCE PRIME stent (Abbott Vascular)
boolean
Male or non-pregnant female
Item
Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
boolean
De novo lesion or restenotic lesion after PTA
Item
De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
boolean
Target lesion length
Item
Target lesion length minimally 30mm and maximally 100mm
boolean
Target vessel diameter
Item
Target vessel diameter >2.0mm and <3.5mm
boolean
Guidewire and delivery system
Item
Guidewire and delivery system successfully traversed lesion
boolean
Refusing treatment
Item
Patient refusing treatment
boolean
Not suitable for stent design
Item
Reference segment diameter not suitable for stent design
boolean
Untreated lesions
Item
Untreated flow-limiting inflow lesions
boolean
Unsuccessful ipsilateral vascular procedure
Item
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
boolean
Previous surgery in the target vessel
Item
Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
boolean
Aneurysm in the target vessel
Item
Aneurysm in the target vessel
boolean
Non-atherosclerotic disease resulting in occlusion
Item
Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
boolean
Medical comorbidities
Item
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
boolean
Major distal amputation
Item
Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
boolean
Septicemia or bacteremia
Item
Septicemia or bacteremia
boolean
Coagulation disorder
Item
Any previously known coagulation disorder, including hypercoagulability
boolean
Contraindications
Item
Contraindication to anticoagulation or antiplatelet therapy
boolean
Allergies
Item
Known allergies to stent or stent components; Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
boolean
Hypersensitivity to heparin
Item
Hypersensitivity to heparin, including patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
boolean
Participating in another clinical research trial
Item
Currently participating in another clinical research trial
boolean
Intra-arterial thrombus
Item
Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
boolean
Target lesion access not performed by transfemoral approach
Item
Target lesion access not performed by transfemoral approach
boolean
Age
Item
Alter
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Rest pain
Item
Ruheschmerz
string
C0234253 (UMLS CUI)
52598005 (SNOMED CT 2010_0731)
10059073 (MedDRA 13.1)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Eligibility
Item
Eligibility Determination
string
C0013893 (UMLS CUI)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
PTA
Item
PTA
string
C0883295 (UMLS CUI)
MTHU012071 (LOINC Version 232)
Vessel lumen diameter
Item
Vessel lumen diameter
string
C1301408 (UMLS CUI)
397413000 (SNOMED CT 2010_0731)
Stent
Item
Stent, device
string
C0038257 (UMLS CUI)
65818007 (SNOMED CT 2010_0731)
10002329 (MedDRA 13.1)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Aneurysm
Item
Aneurysma
string
C0002940 (UMLS CUI)
85659009 (SNOMED CT 2010_0731)
10061169 (MedDRA 13.1)
I72.9 (ICD-10-CM Version 2010)
442.9 (ICD-9-CM Version 2011)
Embolism
Item
Embolism
string
C0013922 (UMLS CUI)
414086009 (SNOMED CT 2010_0731)
10043540 (MedDRA 13.1)
Buerger's disease
Item
Thromboangiitis Obliterans
string
C0040021 (UMLS CUI)
52403007 (SNOMED CT 2010_0731)
10047115 (MedDRA 13.1)
I73.1 (ICD-10-CM Version 2010)
443.1 (ICD-9-CM Version 2011)
Vasculitis
Item
Vaskulitis
string
C0042384 (UMLS CUI)
31996006 (SNOMED CT 2010_0731)
10011078 (MedDRA 13.1)
E13837 (CTCAE Version 4.03)
CAD
Item
Coronary Artery Disease
string
C1956346 (UMLS CUI)
53741008 (SNOMED CT 2010_0731)
10007559 (MedDRA 13.1)
CHF
Item
Congestive heart failure
string
C0018802 (UMLS CUI)
42343007 (SNOMED CT 2010_0731)
10009033 (MedDRA 13.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
COPD
Item
COPD
string
C0024117 (UMLS CUI)
13645005 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
J44.9 (ICD-10-CM Version 2010)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10012267 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C80 (ICD-10-CM Version 2010)
199 (ICD-9-CM Version 2011)
Dementia
Item
Demenz
string
C0497327 (UMLS CUI)
52448006 (SNOMED CT 2010_0731)
10061627 (MedDRA 13.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
Amputation
Item
Amputation
string
C0002688 (UMLS CUI)
81723002 (SNOMED CT 2010_0731)
10040082 (MedDRA 13.1)
84.91 (ICD-9-CM Version 2011)
Septicemia
Item
Septikämie
string
C0036690 (UMLS CUI)
105592009 (SNOMED CT 2010_0731)
10003997 (MedDRA 13.1)
MTHU020833 (LOINC Version 232)
A41.9 (ICD-10-CM Version 2010)
038.9 (ICD-9-CM Version 2011)
E11560 (CTCAE Version 4.03)
Bacteremia
Item
Bakteriämie
string
C0004610 (UMLS CUI)
5758002 (SNOMED CT 2010_0731)
10057396 (MedDRA 13.1)
R78.81 (ICD-10-CM Version 2010)
790.7 (ICD-9-CM Version 2011)
Thrombophilia
Item
Thrombophilie
string
C0398623 (UMLS CUI)
76612001 (SNOMED CT 2010_0731)
10010833 (MedDRA 13.1)
D68.59 (ICD-10-CM Version 2010)
Contraindication to medical treatment
Item
Contraindication to medical treatment
string
C0852648 (UMLS CUI)
Allergy
Item
Allergie
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Heparin
Item
Heparin
string
C0019134 (UMLS CUI)
372877000 (SNOMED CT 2010_0731)
10043554 (MedDRA 13.1)
MTHU003766 (LOINC Version 232)
Thrombopenia
Item
Thrombocytopenia
string
C0040034 (UMLS CUI)
302215000 (SNOMED CT 2010_0731)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE Version 4.03)
Thrombus
Item
Thrombus
string
C0087086 (UMLS CUI)
396339007 (SNOMED CT 2010_0731)
Cholesterol Embolism
Item
Atheroembolism
string
C0149649 (UMLS CUI)
10690002 (SNOMED CT 2010_0731)
I75 (ICD-10-CM Version 2010)
445 (ICD-9-CM Version 2011)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
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