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

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.

Author information

1
Rex Healthcare, Raleigh, NC. Electronic address: George.Adams@rexhealth.com.
2
Metro Health Hospital, Wyoming, MI. Electronic address: jihad.mustapha@metrogr.org.
3
Columbia University Medical Center, New York, NY. Electronic address: wg2131@mail.cumc.columbia.edu.
4
Cardiovascular Systems Inc, St Paul, MN. Electronic address: nhargus@csi360.com.
5
Cardiovascular Systems Inc, St Paul, MN. Electronic address: bmartinsen@csi360.com.
6
Riverside Methodist Hospital, Columbus, OH. Electronic address: garyansel@aol.com.
7
Massachusetts General Hospital, Boston, MA. Electronic address: mjaff@partners.org.

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.

PMID:
26995365
DOI:
10.1016/j.ahj.2015.12.013
[Indexed for MEDLINE]
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