ID

23140

Beskrivning

Responsible Party: C. R. Bard ClinicalTrials.gov Identifier: NCT02262949 History of Changes Other Study ID Numbers: BPV-13-002 DRKS00006281 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: September 25, 2014 Last Updated: December 6, 2016 A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System (REALITY2) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02262949

Länk

https://clinicaltrials.gov/ct2/show/NCT02262949

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Versioner (1)
  1. 2017-06-25 2017-06-25 -
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25 juni 2017

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Eligibility Vascular Stent in Peripheral Artery Disease DRKS00006281 NCT02262949 DRKS00006281

Engelsk

Eligibility Vascular Stent in Peripheral Artery Disease NCT02262949 DRKS00006281

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
Beskrivning

Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C2348563
3. The subject is ≥ 21 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
Beskrivning

Pregnancy Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0032976
5. The subject has lifestyle-limiting claudication or mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
Beskrivning

Mild Claudication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1456822
UMLS CUI [1,2]
C2945599
6. The target lesion has angiographic evidence of stenosis or restenosis ≥50% or occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.
Beskrivning

Peripheral angiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0412290
7. The target vessel reference diameter is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
Beskrivning

Vessel diameter

Datatyp

boolean

Alias
UMLS CUI [1]
C1301408
8. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
Beskrivning

Circulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005775
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
Beskrivning

Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0558080
2. The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
Beskrivning

Claudication Specification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1456822
UMLS CUI [1,2]
C2348235
3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.
Beskrivning

Contraindication, Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0020517
4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
Beskrivning

Contrast Media Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0570562
5. The subject has a history of bleeding diatheses of coagulopathy.
Beskrivning

Bleeding Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
6. The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
Beskrivning

Creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
7. The subject has concomitant hepatic insufficiency,thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.Comorbidity
Beskrivning

Hepatic insufficiency, thrombophlebitis, uremia, SLE, DVT

Datatyp

boolean

Alias
UMLS CUI [1]
C0040046
UMLS CUI [2]
C0041948
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0149871
8. The subject is receiving dialysis or immunosuppressive therapy.
Beskrivning

Dialysis, Immunosuppressive Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0021079
9. The subject is participating in an investigational drug or another investigational device study.
Beskrivning

Study Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
10. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
11. The subject has extensive peripheral vascular disease, which,in the opinion of the investigator, precludes safe insertion of an introducer sheath.
Beskrivning

Extensive peripheral vascular disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
12. The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
Beskrivning

Aneurysm

Datatyp

boolean

Alias
UMLS CUI [1]
C0002940
13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
Beskrivning

Claudication with poor inflow

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1456822
UMLS CUI [1,2]
C0806140
UMLS CUI [1,3]
C0542537
14. The subject is diagnosed with septicemia at the time of the study procedure.
Beskrivning

Septicemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036690
15. Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
Beskrivning

Previous Stenting

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348535
UMLS CUI [1,2]
C0205156
16. Lesions requiring the use of more than one investigational stent.
Beskrivning

Number of Stents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C0449788
17. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days.
Beskrivning

Bilateral disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1511113
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Similar models

Eligibility Vascular Stent in Peripheral Artery Disease NCT02262949 DRKS00006281

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
boolean
C0021430 (UMLS CUI [1])
Study Protocol
Item
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
boolean
C2348563 (UMLS CUI [1])
Age
Item
3. The subject is ≥ 21 years old.
boolean
C0001779 (UMLS CUI [1])
Pregnancy Test
Item
4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
boolean
C0032976 (UMLS CUI [1])
Mild Claudication
Item
5. The subject has lifestyle-limiting claudication or mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
boolean
C1456822 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
Peripheral angiography
Item
6. The target lesion has angiographic evidence of stenosis or restenosis ≥50% or occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.
boolean
C0412290 (UMLS CUI [1])
Vessel diameter
Item
7. The target vessel reference diameter is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
boolean
C1301408 (UMLS CUI [1])
Circulation
Item
8. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
boolean
C0005775 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Unwilling
Item
1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
boolean
C0558080 (UMLS CUI [1])
Claudication Specification
Item
2. The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
boolean
C1456822 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Contraindication, Hypersensitivity
Item
3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.
boolean
C1301624 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
Contrast Media Allergy
Item
4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
boolean
C0570562 (UMLS CUI [1])
Bleeding Disorder
Item
5. The subject has a history of bleeding diatheses of coagulopathy.
boolean
C0005779 (UMLS CUI [1])
Creatinine
Item
6. The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
boolean
C0201976 (UMLS CUI [1])
Hepatic insufficiency, thrombophlebitis, uremia, SLE, DVT
Item
7. The subject has concomitant hepatic insufficiency,thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.Comorbidity
boolean
C0040046 (UMLS CUI [1])
C0041948 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0149871 (UMLS CUI [4])
Dialysis, Immunosuppressive Therapy
Item
8. The subject is receiving dialysis or immunosuppressive therapy.
boolean
C0011946 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Study Participation Status
Item
9. The subject is participating in an investigational drug or another investigational device study.
boolean
C2348568 (UMLS CUI [1])
Comorbidity
Item
10. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
boolean
C0009488 (UMLS CUI [1])
Extensive peripheral vascular disease
Item
11. The subject has extensive peripheral vascular disease, which,in the opinion of the investigator, precludes safe insertion of an introducer sheath.
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Aneurysm
Item
12. The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
boolean
C0002940 (UMLS CUI [1])
Claudication with poor inflow
Item
13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
boolean
C1456822 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
C0542537 (UMLS CUI [1,3])
Septicemia
Item
14. The subject is diagnosed with septicemia at the time of the study procedure.
boolean
C0036690 (UMLS CUI [1])
Previous Stenting
Item
15. Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
boolean
C2348535 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Number of Stents
Item
16. Lesions requiring the use of more than one investigational stent.
boolean
C0038257 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Bilateral disease
Item
17. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days.
boolean
C1511113 (UMLS CUI [1])
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