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.
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.
- 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!