LIBERTY 360º


LIBERTY is the largest, contemporary, real-world experience study to evaluate procedural and long-term clinical outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD).

Study Design1

 

  • Prospective, observational, multicenter study that includes any FDA-cleared or approved technology to treat claudication and critical limb ischemia (CLI).
  • 1204 patients enrolled at 51 sites and were followed for up to 5 years. 4 core labs used for independent analysis.
  • Key endpoints: Procedural and lesion success, Major Adverse Events (MAEs), Duplex Ultrasound (DUS), Quality of Life (QoL), and Six-Minute Walk Test (6MWT).
  • Key inclusion criteria: Rutherford classification (RC) 2 to 6, target lesion located within or extending into 10 cm above the medial epicondyle to the digital arteries (distal 1/3 of the SFA and below), and at least one lesion that can be treated with an endovascular device.

 

Conclusion

Peripheral vascular intervention (PVI) may be a reasonable treatment option across all Rutherford classes with durable results lasting to 3 years.2

  • High freedom from major amputation TVR/TLR at 3 years across all Rutherford classes2
  • In the OAS sub-analysis, freedom from major amputation TVR/TLR rates at 3 years were even higher than in the full patient cohort2
  • Improved Quality of Life by 30 days and maintained to 3 years across all Rutherford classes2
  • High long-term patency rates through 2 years in RC2-33
  • Improvement in mean number of wounds from 30 days to 2 years in RC4-63

 

1. Mustapha JA, et al. One-Year Results of the LIBERTY 360 Study. J Endovasc Ther. 2019;26(2):143-154.
2. Mustapha JA. LIBERTY 360 Trial 3-Year Update. Presented at AMP 2019.
3. Mustapha JA. Late Breaking: LIBERTY 360 Trial 2-Year Update. Presented at AMP 2018.

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