Eligibility NCT01442636 Peripheral Arterial Disease
ODM derived from http://clinicaltrials.gov/show/NCT01442636

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
UMLS CUI
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
Item Group
Age
Item
Alter
string
C0001779
102518004
Diagnosis
Item
Diagnose
string
C0011900
439401001
MTHU008876
Rest pain
Item
Ruheschmerz
string
C0234253
52598005
10059073
Compliance
Item
Compliance
string
C1321605
405078008
Informed Consent
Item
Einverständniserklärung
string
C0021430
Life expectancy
Item
Life expectancy
string
C0023671
LP75025-4
Eligibility
Item
Eligibility Determination
string
C0013893
Contraception
Item
Kontrazeption
string
C0700589
146680009
10010808
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060
166434005
PTA
Item
PTA
string
C0883295
MTHU012071
Vessel lumen diameter
Item
Vessel lumen diameter
string
C1301408
397413000
Stent
Item
Stent, device
string
C0038257
65818007
10002329
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111
Aneurysm
Item
Aneurysma
string
C0002940
85659009
10061169
I72.9
442.9
Embolism
Item
Embolism
string
C0013922
414086009
10043540
Buerger's disease
Item
Thromboangiitis Obliterans
string
C0040021
52403007
10047115
I73.1
443.1
Vasculitis
Item
Vaskulitis
string
C0042384
31996006
10011078
E13837
CAD
Item
Coronary Artery Disease
string
C1956346
53741008
10007559
CHF
Item
Congestive heart failure
string
C0018802
42343007
10009033
MTHU020787
I50.9
428.0
COPD
Item
COPD
string
C0024117
13645005
10028997
J44.9
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826
363346000
10012267
MTHU010328
C80
199
Dementia
Item
Demenz
string
C0497327
52448006
10061627
F03
290
Amputation
Item
Amputation
string
C0002688
81723002
10040082
84.91
Septicemia
Item
Septikämie
string
C0036690
105592009
10003997
MTHU020833
A41.9
038.9
E11560
Bacteremia
Item
Bakteriämie
string
C0004610
5758002
10057396
R78.81
790.7
Thrombophilia
Item
Thrombophilie
string
C0398623
76612001
10010833
D68.59
Contraindication to medical treatment
Item
Contraindication to medical treatment
string
C1301624
Allergy
Item
Allergie
string
C0020517
257550005
T78.40
Heparin
Item
Heparin
string
C0019134
372877000
10043554
MTHU003766
Thrombopenia
Item
Thrombocytopenia
string
C0040034
302215000
D69.6
287.5
E12207
Thrombus
Item
Thrombus
string
C0087086
396339007
Cholesterol Embolism
Item
Atheroembolism
string
C0149649
10690002
I75
445
Enrollment
Item
Enrollment
string
C2348568