CSI's COAST Study Begins Enrollment in Japan

October 27, 2014—Cardiovascular Systems, Inc., announced that the first seven patients in Japan have been enrolled in the COAST (Coronary Orbital Atherectomy System Trial) study, 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) in treating severely calcified coronary lesions in patients with coronary artery disease (CAD). The COAST study is being conducted in the United States and Japan.

Shigeru Saito, MD, performed the procedures on October 27. Dr. Saito is Director of Cardiology and Catheterization Laboratories at Shonan Kamakura General Hospital in Kamakura, Japan. Dr. Saito serves as principal investigator with Gregg Stone, MD, Director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.

In the company’s press release, Dr. Saito commented, “We’re excited to be in CSI’s pivotal COAST study. Today, I used the company’s new micro crown OAS to successfully modify calcified coronary lesions in seven patients. Prepping the vessels with CSI’s technology enabled stent delivery and expansion in these challenging patient cases.”

According to CSI, the COAST study will enroll up to 100 patients at up to 15 sites in the United States and five sites in Japan. Enrollment in the United States began in June 2014.

COAST is a prospective, single-arm, multicenter, global, investigational study designed to evaluate the safety and efficacy of CSI’s micro crown OAS in difficult-to-treat severely calcified lesions. COAST builds on CSI’s pivotal ORBIT II study, which was designed to enroll patients with severely calcified lesions who are typically excluded from all major trials but commonly seen in the real world.

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, stated the company.

This new system is limited by federal law to investigational use and is currently not commercially available in the United States or Japan.