Cardiovascular Systems Enrolls First Patient in Coronary Artery Disease Treatment Trial

Cardiovascular Systems Inc. (CSI) has enrolled the first patient in its Coronary Orbital Atherectomy System Trial (COAST) trial. 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). Arthur Lee, M.D., of North Florida Regional Medical Center, Gainesville, Fla., performed the first procedure.

CAD is a life-threatening condition and leading cause of death in men and women 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.

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.

“During my first procedure using CSI’s new Micro Crown OAS, I modified a calcified lesion allowing stent delivery and expansion,” said Lee. “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.”

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 U.S. sites and five sites in Japan. Minimum enrollment is 50 patients in the United States and 25 in Japan. Gregg Stone, M.D., director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, and Shigeru Saito, M.D., director of cardiology and catheterization laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, are the study’s principal co-investigators.

“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,” said Stone.

“We’re eager to launch our first international coronary study which will support the approval of our next-generation system in the United States and Japan,” added David L. Martin, CSI president and CEO. “COAST aligns with our ORBIT II data protocol and study details—giving CSI a further opportunity to build on the compelling results we delivered in ORBIT II. Additionally, it will highlight the potential benefits of our new Micro Crown and, we hope help secure commercial approval in Japan.”

St. Paul, Minn.-based Cardiovascular Systems makes devices for the treatment of vascular and coronary disease.