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

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 the control Philips CVX300 laser system for lesion pretreatment prior to PCI. The primary endpoint is clinical success, defined as successful PCI with residual stenosis \

Inclusion Criteria: Clinical Inclusion Criteria: 1. Age 18-85 years, male or female. 2. Coronary angiography confirms the need for PCI. 3. Diagnosed with stable angina, silent myocardial ischemia, unstable angina, non-ST-segment elevation myocardial infarction, or STEMI \>7 days. 4. During PCI, the investigator determines that laser atherectomy is required for lesion pretreatment. 5. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent form acknowledging the risks and benefits described in the informed consent document, and able to complete clinical follow-up as required. Angiographic Inclusion Criteria (visual estimate): 1. Target lesion reference vessel diameter (RVD) ≥2.00 mm by visual estimate. 2. Target lesion stenosis ≥70% (visual estimate), or ≥50% and \