REACH PVI - Currently Enrolling | CSI360

REACH PVI – Currently Enrolling


REACH PVI is a prospective, observational, single-arm, multi-center, post-market clinical study designed to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.

Study Design

  • Approximately 50 subjects will be enrolled at up to ten (10) active sites in the United States (U.S.)
  • The primary outcome is defined as successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access related events
  • Subjects will be followed post-procedure through the first standard of care follow-up visit (7-45 days post procedure)

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