Enrollment Complete in Cardiovascular Systems COAST Study

St. Paul, Minn.-based Cardiovascular Systems Inc. (CSI) has completed enrollment for its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in 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 millimeter 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 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 CEO. “We anticipate that the 30-day data will be presented in 2016.”
COAST builds on CSI’s ORBIT II study, reportedly the first trial designed to treat patients with severely calcified lesions who typically are 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 Shigeru Saito, M.D., director of cardiology and catheterization laboratories at Shonan Kamakura General Hospital in Kamakura, Japan, and Gregg Stone, M.D., director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, N.Y.

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. The condition claims more than 600,000 lives in the United States annually. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention.

CSI makes devices that treat vascular and coronary disease.