Cardiovascular Systems, Inc. (CSI) CSII, announced that the first
patient has been enrolled in its post-market study, LIBERTY 360°. The study is
evaluating the acute and long-term clinical and economic outcomes of CSI's
orbital atherectomy system in treating peripheral arterial disease (PAD).
Additionally, LIBERTY 360° is the first study of its kind to compare orbital
atherectomy to all other PAD treatment options in a difficult-to-treat patient
population. Dr. Cezar Staniloae, NYU Medical Center / New York Cardiovascular
Associates, N.Y., the study's principal investigator, performed the first
procedure.
LIBERTY 360° is a prospective, observational, multi-center post-market study.
It will enroll up to 1,200 patients at 100 sites across the United States,
including 500 patients with claudication (painful circulatory problems), 500
who suffer from critical limb ischemia (CLI) (a severe form of PAD), and 200
scheduled for amputation. LIBERTY 360° is the first study of its kind to
specifically include this challenging population and will evaluate numerous
parameters including procedural and lesion success, rate of major adverse
events, duplex ultrasound findings, quality of life, six-minute walk test,
wound status, economic outcomes, and development of plaque burden assessment.
The study's national principal investigators are:
* Claudicant Arm (Rutherford 2-3): Dr. William Gray, Columbia University
Medical Center, New York, NY
* CLI Arm (Rutherford 4-5): Dr. Gary Ansel, Riverside Methodist Hospital,
Columbus, OH, and Dr. George Adams, Rex Healthcare, Raleigh, NC
* CLI Arm (Rutherford 6): Dr. Jihad Mustapha, Metro Health Hospital, Grand
Rapids, MI
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