US-based Cardiovascular Systems (CSI) has started enrolling patients in its coronary orbital atherectomy system trial (COAST), designed to evaluate 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 sisease (CAD).
The micro crown is the company'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.
CSI said that the micro crown OAS is designed to improve tracking and piloting of the OAS driveshaft and the ability of the crown to reach lesions while operating at low rotational speeds.
North Florida Regional Medical Center's Dr Arthur Lee said during his first procedure using CSI's new micro crown OAS, he 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," Lee said.
Building on the company's ORBIT II trial, the first trial is designed to enrol severely calcified lesions that are typically excluded from all major trials but commonly seen in real-world cases, COAST is a prospective, single-arm, multi-centre, global, investigational trial designed to assess the safety and efficacy of CSI's new micro crown OAS in these difficult to treat lesions.
A hundred patients are expected to be enrolled in the trial at around 15 US sites and five sites in Japan.
The company said that minimum enrolment is 50 patients in the US and 25 in Japan.
CSI president and chief executive officer David Martin said: "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."