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 \<30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization through 7 days post-procedure. Secondary endpoints include device success, procedural success, MACE, target lesion failure, and target vessel failure at 30 days and 6 months. An OCT sub-study is planned for 40 subjects.
Age 18-85 years, male or female.
Coronary angiography confirms the need for PCI.
Diagnosed with stable angina, silent myocardial ischemia, unstable angina, non-ST-segment elevation myocardial infarction, or STEMI >7 days.
During PCI, the investigator determines that laser atherectomy is required for lesion pretreatment.
Hemodynamic instability or severely reduced exercise tolerance (NYHA Class III or IV).
Severe heart failure with reduced ejection fraction (LVEF <30%).
Intracardiac thrombus on echocardiography within 30 days prior to enrollment.
Has received an organ transplant or is awaiting an organ transplant.