Liberty 30 Day Title 9.23.16

Prospective, observational, multi-center study to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions with ANY FDA-approved technology in patients with symptomatic lower extremity PAD.
*Click the chart below for a larger view.

51 sites and 131 operators 37 individual operators treated RC6 patients

51 sites and 131 operators
37 individual operators treated RC6 patients

The early findings in this novel all-comers PAD study suggest that “watchful waiting” in RC2-3 and “primary amputation” in RC6 may not be necessary – PVI can be successful in these patient populations as well.

Notable Findings

  • Over 50% of lesions had visible calcification (PACSS) by angiographic core lab analysis
  • Median procedure time (min): 65.0 RC2-3; 71.0 RC4-5; 67.0 RC6
  • High procedural lesion treatment success across all Rutherford Classes (85.6% RC2-3; 80.3% RC4-5; 76.8% RC6)
  • Number of runoff vessels increased post-PVI with significant improvement seen in RC4-5 and RC6 compared to RC2-3. Runoff was worsened post-PVI in less than 6% of patients
  • One of the first procedural and lesion outcome datasets on Rutherford 6 patients. In this study, RC6 subjects resulted in <50% residual stenosis in 83.7% of the lesions treated, no angiographic complications in 89.0% of lesions
  • Procedural complications rarely (0.8%-2.0%) resulted in post-procedural hospitalization in all Rutherford Classes and 78% of RC6 subjects were discharged to home
  • Quality of life improved from baseline at 30-days across all Rutherford Classes (EQ-5D and VascuQoL)
  • LIBERTY will follow patients for up to 5 years; 1 year data is expected summer 2017. Look for further sub-analysis of this data in the near future!