Trial Design:

  • Prospective, multi-center, randomized trial
  • Randomization 2:1 (Ranger DCB vs. Uncoated balloon)
  • 105 patients with femoropopliteal artery lesions
  • 10 sites (Germany, France, and Austria)

Endpoints

Primary endpoint:

  • In-segment late lumen loss of the treated segment, as observed by angiography at six months post-procedure

Secondary endpoints:

  • Restnosis and patency rates
  • Rutherford classification / clinical success
  • Ankle-brachial index / hemodynamic success
  • Quality of life (WIQ, EQ5D, SF12)
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Similar lesion characteristics between Ranger and control groups

 

RangerTM DCB SFA Trial Efficacy and Safety Results

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