COAST Study Commences for CSI's Micro Crown Orbital Atherectomy System

June 11, 2014—Cardiovascular Systems, Inc. (CSI) announced that the first patient has been enrolled in the COAST (Coronary Orbital Atherectomy System Trial) study 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. COAST will enroll patients in the United States and Japan. 

According to CSI, Micro Crown is the company’s second-generation system designed to facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for percutaneous transluminal coronary angioplasty or stenting. The Micro Crown OAS is designed to improve tracking and piloting of the OAS driveshaft, with a crown that is capable of reaching the lesion while operating at low rotational speeds.

COAST is a prospective, single-arm, multicenter, global, investigational study designed to evaluate the safety and efficacy of CSI’s new Micro Crown coronary OAS in these difficult-to-treat lesions. Up to 100 patients may be enrolled at up to 15 sites in the United States and five sites in Japan. Minimum enrollment is 50 patients in the United States and 25 in Japan. 

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

In the company’s press release, Dr. Stone commented, “We’re excited for the potential of CSI’s new Micro Crown OAS device to provide additional treatment options for heavily calcified lesions seen in the ORBIT II study.”

The first procedure in the COAST study was performed by Arthur Lee, MD, of North Florida Regional Medical Center in Gainesville, Florida. Dr. Lee stated in the company’s announcement, “During my first procedure using CSI’s new Micro Crown OAS, I modified a calcified lesion, allowing stent delivery and expansion. I’m encouraged by CSI’s commitment to advancing and improving the technology by expeditiously releasing a second generation of technology in a space that has been stagnant for 25 years.”

CSI stated that the COAST study will build upon ORBIT II, which studied the safety and effectiveness of CSI’s Diamondback 360 coronary OAS in treating severely calcified lesions in coronary arteries. One-year data from ORBIT II were recently presented at the Society for Cardiovascular Angiography and Interventions 2014 conference, which took place May 28–31, in Las Vegas, Nevada. The ORBIT II data were also presented at the EuroPCR 2014 conference, which took place May 20–23, in Paris, France.