Clinical trial NCT02262949: A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
Official title: A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System (REALITY2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.


Eligibility criteria: Inclusion Criteria:

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).
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. The subject is ≥ 21 years old.
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.
5. The subject has lifestyle-limiting claudication or mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
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.
7. The target vessel reference diameter is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
8. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Exclusion Criteria:

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.
2. The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.
4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
5. The subject has a history of bleeding diatheses of coagulopathy.
6. The subject has concomitant renal failure with a creatinine of \>2.5 mg/dL.
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.
8. The subject is receiving dialysis or immunosuppressive therapy.
9. The subject is participating in an investigational drug or another investigational device study.
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.
11. The subject has extensive peripheral vascular disease, which,in the opinion of the investigator, precludes safe insertion of an introducer sheath.
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.
13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
14. The subject is diagnosed with septicemia at the time of the study procedure.
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.
16. Lesions requiring the use of more than one investigational stent.
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.

Primary outcomes:
measure: Major Adverse Events (MAEs)
timeFrame: 30 days
measure: Stent performance
timeFrame: intra operative
Secondary outcomes:
measure: Major Adverse Events (MAEs)
timeFrame: 1 year
measure: Target lesion/vessel revascularization
timeFrame: 1 year
measure: Target lesion patency
timeFrame: 1 year
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: University Heart Centre Freiburg
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Radiologie
city: Bruchsal
country: Germany
facility: Fürst Stirum Klinik Bruchsal
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
Study officials:
affiliation: University Heart Centre Freiburg, Bad Krozingen
name: Thomas Zeller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: