CSI Completes COAST Enrollment in Japan

December 1, 2014—Cardiovascular Systems, Inc. (CSI) announced that it has completed enrollment in Japan for its COAST (Coronary Orbital Atherectomy System Trial) study. The study, which is taking place in both Japan and the United States, is designed to assess the safety and efficacy, as well as economic outcomes, of the company’s investigational micro crown orbital atherectomy system (OAS) in treating severely calcified coronary lesions in patients with coronary artery disease.

According to the company, COAST requires a minimum of 50 patients in the United States at up to 15 sites and a minimum of 25 patients across five sites in Japan for a total of 100 patients to be enrolled. CSI surpassed its required number of enrollments in Japan with a total of 26 patients on November 20, 2014. In the United States, enrollment is expected to be completed in 2015.

CSI stated that the 1.25-mm micro crown is the company’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 drive shaft and the ability of the crown to reach the lesion while operating at lower rotational speeds.

Building on CSI’s ORBIT II study, which studied 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, multicenter, global, investigational study.

The study’s principal investigators 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.

Dr. Saito commented in the company’s press release, “I’ve used CSI’s new micro crown OAS to successfully modify severely calcified coronary lesions in several patients. This technology allowed for successful stent delivery and expansion in very challenging patient cases.”