Cardiovascular Systems has completed enrolment in COAST (Coronary orbital atherectomy system trial), which is designed to assess the safety and efficacy, as well as economic outcomes, of the company’s new micro crown Orbital Atherectomy System (OAS) for the management of severely calcified coronary lesions in patients with coronary artery disease.
A company press release reports that the 1.25 mm micro crown is Cardiovascular Systems’ second-generation device designed to facilitate stent delivery in patients with severely calcified lesions who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. It adds that 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.
COAST builds on CSI’s ORBIT II study, which was the first trial designed to treat patients with severely calcified lesions who are typically excluded from all major trials but who are commonly seen in the “real world”. It is a prospective, single-arm, multicentre, global, investigational study. David L Martin, CSI president and chief executive officer, says: “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. We anticipate that the 30-day data will be presented in calendar 2016.”
In November 2014, Cardiovascular Systems completed the enrolment of 26 patients at five sites in Japan. Seventy-four patients were enrolled in 15 sites in the USA. The study’s principal co-investigators are Shigeru Saito (director of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan) and Gregg Stone (director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, USA).