Enrollment Completed in CSI's COAST Study of the Coronary Micro Crown OAS

July 13, 2015—Cardiovascular Systems, Inc. (CSI) announced that enrollment has been completed for its COAST (Coronary Orbital Atherectomy System Trial) study. A total of 100 patients were enrolled, including 74 patients at 15 sites in the United States and 26 patients at five sites in Japan. The study was completed in Japan in November 2014.

According to CSI, COAST is a prospective, single-arm, multicenter, global, investigational study. It 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 with coronary artery disease. Data from the COAST study will be used to support regulatory approval for the coronary micro crown OAS in the United States and Japan. The company expects that 30-day data from COAST will be presented in 2016.

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 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.

The company advised that COAST builds on CSI’s ORBIT II study, which was designed to treat patients with severely calcified lesions who are typically excluded from all major trials, but commonly seen in the real world. 

The study’s principal coinvestigators are Shigeru Saito, MD and Gregg Stone, MD. Dr. Saito is Director of Cardiology and Catheterization Laboratories at Shonan Kamakura General Hospital in Kamakura, Japan. Dr. Stone is Director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.