George L Adams1, Jihad Mustapha2, William Gray3, Nick J Hargus4, Brad J Martinsen5, Gary Ansel6, Michael R Jaff7. 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.
RCT Entities:
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.
Authors: Stefanos Giannopoulos; Nicolas W Shammas; Ian Cawich; Cezar S Staniloae; George L Adams; Ehrin J Armstrong Journal: Vasc Health Risk Manag Date: 2020-07-08
Authors: Jihad Mustapha; William Gray; Brad J Martinsen; Ryan W Bolduan; George L Adams; Gary Ansel; Michael R Jaff Journal: J Endovasc Ther Date: 2019-02-06 Impact factor: 3.487
Authors: Jihad A Mustapha; Zsuzsanna Igyarto; David O'Connor; Ehrin J Armstrong; Anthony R Iorio; Vickie R Driver; Fadi Saab; Ann N Behrens; Brad J Martinsen; George L Adams Journal: Vasc Health Risk Manag Date: 2020-02-10
Authors: Stefanos Giannopoulos; Eric A Secemsky; Jihad A Mustapha; George Adams; Robert E Beasley; George Pliagas; Ehrin J Armstrong Journal: J Endovasc Ther Date: 2020-07-03 Impact factor: 3.487
Authors: Philip Goodney; Samir Shah; Yiyuan David Hu; Bjoern Suckow; Scott Kinlay; David G Armstrong; Patrick Geraghty; Megan Patterson; Matthew Menard; Manesh R Patel; Michael S Conte Journal: J Vasc Surg Date: 2022-01-24 Impact factor: 4.860
Authors: E Hope Weissler; Dennis I Narcisse; Jennifer A Rymer; Ehrin J Armstrong; Eric Secemsky; William A Gray; Jihad A Mustapha; George L Adams; Gary M Ansel; Manesh R Patel; W Schuyler Jones Journal: Vasc Endovascular Surg Date: 2020-10-23 Impact factor: 1.089
Authors: Dennis I Narcisse; Elizabeth Hope Weissler; Jennifer A Rymer; Ehrin J Armstrong; Eric A Secemsky; William A Gray; Jihad A Mustapha; George L Adams; Gary M Ansel; Manesh R Patel; William Schuyler Jones Journal: Clin Cardiol Date: 2020-08-11 Impact factor: 2.882