Cardiovascular Systems Enrolls First Seven Patients in Japan for COAST Study

Cardiovascular Systems Inc. (CSI) has enrolled the first Japanese patients in its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in the United States and Japan, the study is designed 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 suffering from Coronary Artery Disease (CAD).

Shigeru Saito, M.D., director of Cardiology and Catheterization Laboratories at Shonan Kamakura General Hospital in Kamakura, Japan, performed the procedures.

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.

“We’re excited to be in CSI’s pivotal COAST study,” said Saito. “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.”

Building on CSI’s ORBIT II study, the first study designed to enroll 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, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in treating these difficult lesions.

Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Enrollment in the United States began in June 2014. Gregg Stone, M.D., director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, NY., and Saito are the study’s principal co-investigators.

“COAST highlights our continued commitment to improving CSI’s leading technology to modify calcified lesions throughout the body,” said David L. Martin, CSI president/CEO. “Enrollment of the first patients in Japan is a key milestone and allows us to begin collecting the valuable data to support approval of our micro crown OAS in the world’s two largest coronary markets.”

CAD is a life-threatening condition and leading cause of death in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events.