ID

4869

Description

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

Link

http://clinicaltrials.gov/show/NCT01442636

Keywords

Versions (2)
  1. 2/7/12 2/7/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01442636 Peripheral Arterial Disease

German English

Eligibility

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

Inclusion Criteria

Age >18 Years
Description

Age

Data type

boolean

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

Rest pain or minor tissue loss

Data type

boolean

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

Compliance

Data type

boolean

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

Informed Consent

Data type

boolean

Life-expectancy of at least 12 months
Description

Life-expectancy

Data type

boolean

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

Eligibility

Data type

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
Description

Male or non-pregnant female

Data type

boolean

Angiographic Inclusion Criteria
Description

Angiographic Inclusion Criteria

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

De novo lesion or restenotic lesion after PTA

Data type

boolean

Target lesion length minimally 30mm and maximally 100mm
Description

Target lesion length

Data type

boolean

Target vessel diameter >2.0mm and <3.5mm
Description

Target vessel diameter

Data type

boolean

Guidewire and delivery system successfully traversed lesion
Description

Guidewire and delivery system

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Patient refusing treatment
Description

Refusing treatment

Data type

boolean

Reference segment diameter not suitable for stent design
Description

Not suitable for stent design

Data type

boolean

Untreated flow-limiting inflow lesions
Description

Untreated lesions

Data type

boolean

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

Unsuccessful ipsilateral vascular procedure

Data type

boolean

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

Previous surgery in the target vessel

Data type

boolean

Aneurysm in the target vessel
Description

Aneurysm in the target vessel

Data type

boolean

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

Non-atherosclerotic disease resulting in occlusion

Data type

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
Description

Medical comorbidities

Data type

boolean

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

Major distal amputation

Data type

boolean

Septicemia or bacteremia
Description

Septicemia or bacteremia

Data type

boolean

Any previously known coagulation disorder, including hypercoagulability
Description

Coagulation disorder

Data type

boolean

Contraindication to anticoagulation or antiplatelet therapy
Description

Contraindications

Data type

boolean

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

Allergies

Data type

boolean

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

Hypersensitivity to heparin

Data type

boolean

Currently participating in another clinical research trial
Description

Participating in another clinical research trial

Data type

boolean

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

Intra-arterial thrombus

Data type

boolean

Target lesion access not performed by transfemoral approach
Description

Target lesion access not performed by transfemoral approach

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Pain at rest
Description

Rest pain

Data type

string

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

Compliance

Data type

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Life expectancy
Description

Life expectancy

Data type

string

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

Eligibility

Data type

string

Alias
UMLS CUI
C0013893
Contraception
Description

Contraception

Data type

string

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

Serum pregnancy test

Data type

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
Percutaneous transluminal angioplasty of vessel
Description

PTA

Data type

string

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

Vessel lumen diameter

Data type

string

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

Stent

Data type

string

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

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111
Aneurysm
Description

Aneurysm

Data type

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
Description

Embolism

Data type

string

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

Buerger's disease

Data type

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
Vasculitis
Description

Vasculitis

Data type

string

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

CAD

Data type

string

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

CHF

Data type

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
Chronic Obstructive Pulmonary Disease
Description

COPD

Data type

string

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

Malignant Neoplasms

Data type

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
Dementia
Description

Dementia

Data type

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
Description

Amputation

Data type

string

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

Septicemia

Data type

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
Bacteremia
Description

Bacteremia

Data type

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
Hypercoagulability
Description

Thrombophilia

Data type

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
Description

Contraindication to medical treatment

Data type

string

Alias
UMLS CUI
C1301624
Hypersensitivity
Description

Allergy

Data type

string

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

Heparin

Data type

string

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

Thrombopenia

Data type

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
Description

Thrombus

Data type

string

Alias
UMLS CUI
C0087086
SNOMED CT 2010_0731
396339007
Atheroembolism
Description

Cholesterol Embolism

Data type

string

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

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
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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
Item
Age >18 Years
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
Item Group
Angiographic Inclusion Criteria
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
Item Group
Exclusion Criteria
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
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Rest pain
Item
Pain at rest
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
Informed Consent
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)
Contraception
Item
Contraception
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
Percutaneous transluminal angioplasty of vessel
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
Aneurysm
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
Vasculitis
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
Chronic Obstructive Pulmonary Disease
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
Dementia
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
Septicemia
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
Bacteremia
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
Hypercoagulability
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
C1301624 (UMLS CUI)
Allergy
Item
Hypersensitivity
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
C2348568 (UMLS CUI)
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