title: 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.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Rex Healthcare, Raleigh, NC. Electronic address: George.Adams@rexhealth.com.
authors.forename: George L
authors.initials: GL
authors.lastname: Adams
authors.affiliation: Metro Health Hospital, Wyoming, MI. Electronic address: jihad.mustapha@metrogr.org.
authors.forename: Jihad
authors.initials: J
authors.lastname: Mustapha
authors.affiliation: Columbia University Medical Center, New York, NY. Electronic address: wg2131@mail.cumc.columbia.edu.
authors.forename: William
authors.initials: W
authors.lastname: Gray
authors.affiliation: Cardiovascular Systems Inc, St Paul, MN. Electronic address: nhargus@csi360.com.
authors.forename: Nick J
authors.initials: NJ
authors.lastname: Hargus
authors.affiliation: Cardiovascular Systems Inc, St Paul, MN. Electronic address: bmartinsen@csi360.com.
authors.forename: Brad J
authors.initials: BJ
authors.lastname: Martinsen
authors.affiliation: Riverside Methodist Hospital, Columbus, OH. Electronic address: garyansel@aol.com.
authors.forename: Gary
authors.initials: G
authors.lastname: Ansel
authors.affiliation: Massachusetts General Hospital, Boston, MA. Electronic address: mjaff@partners.org.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D003362:Cost-Benefit Analysis; D057510:Endovascular Procedures / Q000191:economics / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D017721:Hospital Costs / Q000639:trends*; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000191:economics / Q000601:surgery*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States