June 20, 2013 — Cardiovascular Systems Inc. (CSI) announced that the first patient has been enrolled in its post-market clinical 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. Cezar Staniloae, NYU Medical Center / New York Cardiovascular Associates, N.Y., the study’s principal investigator, performed the first procedure.
“Moreover, our patient population includes complex cases, even those with advanced and severe PAD — a subset that hasn’t been studied before.”
“LIBERTY 360° is unique because it’s assessing success based on long-term outcomes and durability — rather than acute angiographic results of the various treatments,” said Staniloae. “Moreover, our patient population includes complex cases, even those with advanced and severe PAD — a subset that hasn’t been studied before.”
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): William Gray, Columbia University Medical Center, New York, N.Y.
- CLI Arm (Rutherford 4-5): Gary Ansel, Riverside Methodist Hospital, Columbus, OH, and George Adams, Rex Healthcare, Raleigh, N.C.
- CLI Arm (Rutherford 6): Jihad Mustapha, Metro Health Hospital, Grand Rapids, Mich.
David L. Martin, CSI president and chief executive officer commented, “Past studies have proven that treating PAD patients with our orbital atherectomy system is safe and effective. The LIBERTY 360° study is a massive undertaking looking at a large number of the most difficult-to-treat patients. CSI is an industry leader in clinical data support for our physician customers, and we’re dedicated to providing them with the information they need to make sound treatment decisions for their patients. LIBERTY 360° is the latest example of our commitment to this and we’re excited about the data and insight it will provide.”
In the fall of 2012, data from another CSI PAD post market study, the CONFIRM series, demonstrated that the company’s minimally invasive orbital atherectomy system is a safe and effective treatment for PAD. CONFIRM explored outcomes in more than 3,000 patients and 4,700 lesions in a real-world setting, and showed that CSI’s orbital atherectomy system safely removes plaque in calcified lesions, with less than 1 percent perforations, about 2 percent distal embolization and vessel closure, and less than 6 percent bail-out stenting due to dissections — preserving future treatment options. Results also demonstrated improved lesion compliance, with a low mean inflation of less than 6 atms for adjunctive balloon therapy. Safe and effective results, similar to those achieved in hospital settings, were also demonstrated in an office-based-lab setting.
For more information: www.csi360.com