Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System
Condition: Efficacy of the Study Device
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of this registry is to determine the efficacy and safety of the self-expanding, extra
      flexible FlexStent in patient with superficial femor/popliteal artery disease.

      The stent has been developed to cope with the extreme requirements of the femoral artery/knee
      artery and is approved for usage at humans (EC-certified). It is designed to treat narrows of
      the femoral- and knee artery.

      100 patients at 5 German hospital shall be enrolled. After stent implantation follow-up
      visits at 6 and 12 month take place.
    

Detailed description: 
      Peripheral arterial disease (PAD) represents a major challenge to physicians in treating the
      Superficial Femoral (SFA) and Popliteal arteries. These arteries represent a harsh
      environment for any endovascular device. This disease is characterized by long occlusions
      with relatively low flow and with the vessels exposed to enormous mechanical stress. During
      flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress
      dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great
      ranges of movement while adequately supporting the arteries.

      The FlexStent® stent provides a great range of motions for a highly flexible femoral artery
      while adequately supporting the vessel. The intended use for the FlexStent® stent is for the
      treatment of symptomatic femoropopliteal disease, primarily for atherosclerotic de novo
      native superficial femoral artery lesions.

      The intent of this clinical registry is to demonstrate the efficacy and safety of the
      FlexStent® stent in patients with superficial femoral/ popliteal artery disease.

      Hypothesis: the FlexStent® will be safe and efficacious in treating SFA/popliteal artery
      diseases.

      Primary object: evaluation of efficacy of the FlexStent® measured by the in-stent restenosis
      using DUS following treatment, 6 and 12 MFU visits.
    

Intervention name(s): FlexStent Femoropopliteal Self-Expanding Stent System
Intervention type(s): Device
Intervention description(s): Peri-procedural management will be no different to routine SFA/Popliteal Artery intervention Standard medical therapy
Procedural techniques will be identical to routine protocols for SFA/Popliteal Artery stenting. technique suggested:
Contralateral retrograde common femoral cross-over access or antegrade access
Target lower limb arteries fully imaged angiogram. with measurement of SFA/Popliteal Artery target lesion length and normal vessel diameter immediately above and below target lesion
Pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis
Deployment of an appropriately sized FlexStent® to cover target lesion
Post-stent balloon dilate stent using a semi-compliant angioplasty balloon to enable accurate post-dilatation of stent to target diameter
Post stenting angiography assessing target lesion parameters, run-off vessel patency and complications
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAD