Cardiovascular Systems has announced that the first patient has been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) trial.
Taking place in the US and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of Cardiovascular Systems’ new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from coronary artery disease (CAD).
Dr Arthur Lee from North Florida Regional Medical Center, Gainesville, performed the first procedure.
The micro crown is CSI’s second-generation system designed to facilitate stent delivery in subjects with CAD 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 low rotational speeds.
Building on CSI’s ORBIT II study, the first study designed to enroll severely calcified lesions that are typically excluded from all major trials but commonly seen in the real world cases, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in these difficult to treat lesions.
Up to 100 subjects may be enrolled at up to 15 US. sites and five sites in Japan. Minimum enrollment is 50 patients in the US and 25 in Japan.
Dr Gregg Stone, director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, and Dr Shigeru Saito, director of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, are the study’s principal co-investigators.