A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)

NCT ID: NCT01920308

Last Updated: 2016-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

5 mm Bard LifeStent Vascular Stent

The study population will be comprised of subjects who present with moderate lifestyle-limiting claudication to mild tissue loss (Rutherford Category 2-5) that are candidates for PTA and stenting.

Subjects with lesion(s) in the infra-inguinal segment (SFA and/or popliteal artery) will be considered for enrollment. The reference vessel diameter will be appropriate for treatment with available stent diameter of 5.0 mm (by visual estimate).

5 mm Bard LifeStent Vascular Stent

Intervention Type: DEVICE

The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.

Interventions

5 mm Bard LifeStent Vascular Stent

The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.

Intervention Type: DEVICE

Other Intervention Names

Bard LifeStent Vascular Stent System; SFA stenting

Eligibility Criteria

Inclusion Criteria

• 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)
• Subject agrees to comply with the protocol-mandated follow-up procedures and visits
• The subject is ≥ 21 years old
• 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
• The subject has moderate lifestyle-limiting claudication to mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss
• The target lesion(s) 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
• The target vessel reference diameter will be (by visual estimate) appropriate for treatment with available stent diameter of 5.0 mm
• A total of two stents may be used to cover lesions. Overlapping is allowed
• There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus

Exclusion Criteria

• 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
• The subject has claudication or critical limb ischemia described as Rutherford Category1 0 (asymptomatic), 1 ( mild claudication), or 6 (major tissue loss)
• The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum
• The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines
• The subject has a history of bleeding diatheses or coagulopathy
• The subject has concomitant renal failure with a creatinine of >2.5 mg/dL
• The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure
• The subject is receiving dialysis or immunosuppressive therapy
• The subject is participating in an investigational drug or another investigational device study
• The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years
• The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath
• The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s)
• The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft
• The subject is diagnosed with septicemia at the time of the study procedure
• Patients with a stent previously implanted into the target vessel
• Lesions requiring the use of more than two stents

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Heart Centre in Bad Krozingen

Locations

University Heart Centre Bad Krozingen

Bad Krozingen, , Germany

Countries

Germany

Other Identifiers

BPV-13-001

Identifier Type: -

Identifier Source: org_study_id