The LIBERTY Study: Design of a Prospective, Observational, Multicenter Trial to Evaluate the Acute and Long-Term Clinical and Economic Outcomes of Real-World Endovascular Device Interventions in Treating Peripheral Artery Disease

Am Heart J. 2016 Apr;174:14-21. doi: 10.1016/j.ahj.2015.12.013. Epub 2015 Dec 30.

Abstract

Background: Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations.

Study design: LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population.

Conclusion: LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy.

Trial registration: ClinicalTrials.gov NCT01855412.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cost-Benefit Analysis
  • Endovascular Procedures / economics
  • Endovascular Procedures / instrumentation*
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Hospital Costs / trends*
  • Humans
  • Male
  • Peripheral Arterial Disease / economics
  • Peripheral Arterial Disease / surgery*
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • United States

Associated data

  • ClinicalTrials.gov/NCT01855412