Bard® LifeStent® Vascular Stent Delivery System Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- C. R. Bard
- Enrollment
- 76
- Locations
- 8
- Primary Endpoint
- Acute Effectiveness: Percentage of Stents With Successful Delivery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
Detailed Description
Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent. Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.
Investigators
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 lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
- •The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
- •The total treated segment(s) must be ≤ 240 mm.
- •The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
- •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 1 (mild claudication), 5 (minor tissue loss) 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.
Outcomes
Primary Outcomes
Acute Effectiveness: Percentage of Stents With Successful Delivery
Time Frame: At implantation (Day 0)
Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.
Time Frame: 30 day follow-up
Safety: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
Secondary Outcomes
- Primary Target Lesion Patency(12 months post-index procedure)