OPTIMIZE - Follow-Up Phase | CSI360

OPTIMIZE – Follow-Up Phase

Optimize Clinical Study

OPTIMIZE is a prospective, randomized one to one (1:1), multi-center European pilot study designed to evaluate Orbital Atherectomy vessel preparation prior to drug coated balloons (DCBs) compared to DCB alone for the treatment of calcified below-the-knee lesions.

Study Design

  • Approximately 50 patients will be enrolled at up to 10 European sites and followed for up to 2 years
  • Late lumen loss at 6 months post-procedure will be an outcome measure

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