Clinical Trial: Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)

U.S., July 14 -- ClinicalTrials.gov registry received information related to the study (NCT07697638) titled 'Coronary Laser Atherectomy System for Treatment of Coronary Artery Stenosis (SHINE)' on July 05.

Brief Summary: This prospective, multi-center clinical trial evaluates the safety and efficacy of the Coronary Laser Atherectomy System for the pretreatment of coronary artery stenosis. The study consists of two phases: a first-in-human (FIM) phase enrolling 5 subjects in a single center, and a pivotal phase, which is a prospective, multi-center, randomized controlled, non-inferiority trial enrolling 218 subjects across approximately 10 centers in China. Subjects are randomized 1:1 to receive either the investigational laser system or th...