Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The aim of this clinical trial is to evaluate the safety and efficacy of the novel Luminor®
      paclitaxel drug-eluting balloon (iVascular, S.L.U., Barcelona, Spain) in inhibiting
      restenosis and in ensuring long-term patency.
    

Detailed description: 
      The investigational medical device represents the Paclitaxel drug-eluting Luminor®-35 balloon
      catheter which is based on a proprietary transfertech coating technology. This has been
      engineered to improve clinical efficacy by optimizing coating properties and device
      functionalities. This allows a homogeneous and precise Paclitaxel concentration of 3 μg/mm2
      on the PTA balloon surface. The balloon dilatation procedure, including deployment to the
      target lesion and balloon inflation, deflation and retrieval, is performed under fluoroscopic
      observation. All sites shall have access to an emergency unit to perform also interventions
      as bypass surgery e.g. in case of failed percutaneous transluminal angioplasty (PTA). The
      patient is positioned on the angiographic table and draped in a sterile fashion. The standard
      vascular access represents the ipsilateral or contralateral femoral artery in accordance to
      the target vessel. The endovascular procedure can be performed in a direct antegrade or a
      cross-over retrograde technique.

      An introducer sheath will be inserted over a guidewire. 5.000 I.U. heparin is injected i.a.
      to pre-vent peri-procedural thrombotic events. Alternative peri-procedural anti-coagulation
      regimens may be applied if justified by individual patient requirements. An endoluminal
      guidewire passage of the stenotic and occlusive femoro-popliteal lesion is mandatory for
      study inclusion.

      A POBA PTA balloon of appropriate balloon diameter and length, and catheter working length is
      selected according to the characteristics of the target vessel and lesion for the
      pre-dilation and assessed by angiography (DSA or XA). A ruler has to be adjacent to the
      target vessel. After pre-dilatation of the target lesion an angiographic assessment will be
      performed (DSA or XA). A ruler has to be adjacent to the target vessel.

      Randomization will be performed by envelope pull. The treatment group represents the
      Lumi-nor® DEB and the control group POBA applying a CE-marked non-drug-eluting PTA balloon
      catheter. In patients with peripheral artery disease, quantitative vascular angiography (QVA)
      is essential for the analysis of the degree of the arterial stenosis. For quantitative
      assessment of stenotic lesions, the residual lumen at the lesion site is compared with the
      lumen at a reference site.

      QVA will be assessed by an independent core lab. The assessment during the angioplasty is
      performed pre- and post-procedure, at 6 months follow-up and any unscheduled procedure if
      necessary. Follow-up (FU) assessments will occur at pre-discharge, 6, 12 and 24 months
      following the study procedure.
    

Intervention name(s): Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries; Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter
Intervention type(s): Device; Device
Intervention description(s): Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization.
Luminor35®-DEB PTA catheter is applied.; Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied.
Other intervention name(s): DEB; POBA
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: DEB, drug-eluting balloon, Paclitaxel, peripheral artery disease