International Coronary Trial to Assess the
Safety and Efficacy of New Coronary Micro Crown
ST. PAUL, Minn.,
Cardiovascular Systems, Inc., announced that it has completed enrollment
for its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place
in both Japan and the
United States, the study is designed to assess the safety and
efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital
Atherectomy System (OAS) in treating severely calcified coronary lesions in
patients suffering from Coronary Artery Disease (CAD). As designed, a total of
100 patients were enrolled in the study.
The 1.25 mm micro crown is CSI’s second-generation system
designed to facilitate stent delivery in patients with severely calcified
lesions who are acceptable candidates for percutaneous transluminal coronary
angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the
tracking and piloting of the OAS driveshaft and the ability of the crown to
reach the lesion while operating at lower rotational speeds.
“Data from this study will be key to secure approval for
the use of the coronary micro crown OAS in the world’s two largest atherectomy
markets,” said David
L. Martin, CSI president and chief executive officer. “We anticipate
that the 30-day data will be presented in calendar 2016.”
COAST builds on CSI’s ORBIT II study, the first trial
designed to treat patients with severely calcified lesions who are typically
excluded from all major trials, but commonly seen in the real world. COAST is a
prospective, single-arm, multi-center, global, investigational study.
In November
2014, CSI completed the enrollment of 26 patients at five sites in Japan.
Seventy-four patients were enrolled in 15 sites in the
United States. The study’s principal co-investigators are Dr. Shigeru
Saito, Director of Cardiology
and Catheterization Laboratoriesat Shonan
Kamakura General Hospital, Kamakura, Japan and Dr. Gregg
Stone, Director of the Cardiovascular Research and Education
Center for Interventional Vascular Therapy atColumbia
University Medical Center, New
York.
About Coronary
Artery Disease
CAD is a life-threatening condition and a leading cause of death in men and
women in the
United States. CAD occurs when a fatty material called plaque builds
up on the walls of arteries that supply blood to the heart. The plaque buildup
causes the arteries to harden and narrow (atherosclerosis), reducing blood
flow. The risk of CAD increases if a person has one or more of the following:
high blood pressure, abnormal cholesterol levels, diabetes, or family history
of early heart disease. According to the American
Heart Association, 16.3 million people in the
United States have
been diagnosed with CAD, the most common form of heart disease. Heart disease
claims more than 600,000 lives in the
United States each
year. According to estimates, significant arterial calcium is present in nearly
40 percent of patients undergoing a percutaneous coronary intervention (PCI).
Significant calcium contributes to poor outcomes and higher treatment costs in
coronary interventions when traditional therapies are used, including a
significantly higher occurrence of death and major adverse cardiac events
(MACE).
Source: Cardiovascular Systems, Inc.
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