Last updated on February 2016

Treatment of SFA Lesions With 480 Biomedical STANZA Drug-Eluting Resorbable Scaffold (DRS) System


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Intermittent Claudication | Peripheral Arterial Disease | Cardiovascular Diseases | Vascular Diseases
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Age > 18 years.
    De novo stenotic lesion(s) in the superficial femoral artery located at least 1 cm
    distal to the femoral bifurcation and > 5 cm above the joint space of the knee.
    Patient has symptomatic intermittent claudication affecting at least the target leg
    (Rutherford Class 2-3). Patients should have first received conservative medical
    management of their symptoms prior to study inclusion. The symptoms can be bilateral.
    The study patient has been informed of the nature of the study, agrees to its
    provisions and has provided written informed consent as approved by the ethics
    committee of the respective clinical site.
    The study patient agrees to comply with all required post-procedure study
    requirements.
    Baseline Inclusion Criteria
    Reference vessel diameter (RVD) 5.0 -6.0 mm measured by an objective measurement such
    as online Quantitative Vessel Analysis (QVA).
    Target lesion length ≤ 90 mm; total occlusion length < 40 mm.
    Target lesion has a ≥70% diameter stenosis.
    Angiographic evidence of at least one runoff vessel to the ankle/foot without
    hemodynamically significant stenosis (>50% diameter stenosis) that does not require
    any treatment within 3 months of the index procedure.
    Procedural access can be accomplished via contralateral vascular access or if
    antegrade access no closure device can be utilized and closure has to occur via
    manual pressure.
    Patent common and external iliac: TASC A & B iliac lesions may be treated at the time
    of index procedure (before treatment of the target lesion) if residual stenosis is
    ≤30%.

You may not be eligible for this study if the following are true:

  • Previous vascular surgery/endovascular treatment of the target lesion.
    Re-vascularization of target vessel within 30 days of study procedure.
    Critical limb ischemia defined as Rutherford Becker Category 4-6.
    Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or
    ticlopidine, heparin, any scaffold components, contrast agents which cannot be
    adequately pre-medicated.
    Life expectancy ≤12 months.
    Planned procedure that necessitates the discontinuation of antiplatelet medications
    used in conjunction with the investigational device within 3 months post-procedure.
    Inability to walk due to orthopedic or other nonvascular complications.
    Pregnancy or breast feeding or patient desires to become pregnant.
    Non-atherosclerotic lesion (e.g. vasculitis).
    Renal insufficiency (serum creatinine level > 220 µmol/L or > 2.5 mg/dl, or patient
    is on dialysis).
    Patient has medical condition(s) which could affect study assessments or may
    adversely affect the safety and/or success of the study treatment.
    Active systemic infection or lower limb infection of any nature.
    White Blood Cells (WBC) ≤ 3,000 cells/mm3.
    Myocardial infarction within 30 days prior to the study procedure.
    Stroke within 90 days prior to the study procedure.
    Uncontrolled atrial fibrillation.
    Currently participating in an investigational drug or another device study. Note:
    Trials requiring extended follow-up for products that were investigational, but have
    ince become commercially available, are not considered investigational trials.
    Prior use of paclitaxel-eluting products in the target limb less than 6 months prior
    to index procedure.
    Patient has known unstable angina.
    Baseline Exclusion Criteria
    Target lesion treatment with a drug eluting balloon.
    Target lesion treatment with atherectomy, laser, or cryoplasty (use of a cutting or
    coring balloon is permitted prior to scaffold implantation only).
    Suspicion for or evidence of subintimal passage of guidewire.
    Severely calcified lesion(s).
    Target lesion which, based on two angiographic orthogonal views, exhibit a persistent
    balloon deformity during pre-dilatation with a nominally sized balloon.
    Target vessel (superficial femoral artery) has an angiographically significant (> 50%
    diameter stenosis) lesion located distally or proximally to the target lesion.
    Acute embolic complication following pre-dilatation.
    Target vessel contains an acute thrombus.
    Aneurysm in target vessel or co-existing clinically significant aneurysmal disease of
    the abdominal aorta, iliac or popliteal arteries.
    Intervention in the infra-inguinal arteries outside of the target lesion.
    Planned procedure within 30 days after the index procedure.
    Positive pregnancy test for females of child bearing potential.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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