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.
Parallel
Coronary Laser Atherectomy System
DeviceThe investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.
CVX300 Laser System
DeviceThe control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters.
Clinical Success Rate
Clinical success is defined as target lesion after laser pretreatment, completion of PCI, and coronary angiography confirmed residual stenosis \<30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization during the perioperative period (up to 7 days post-procedure).
Device Success Rate
Device success is defined as a target lesion after laser pretreatment, completion of PCI, and coronary angiography confirmed residual stenosis \<30%, TIMI flow grade 3.
Procedural Success Rate
Procedural success is defined as device success in the absence of procedure-related complications.
Procedure-related Complication Rate
Procedure-related complications is defined as stroke, vessel perforation or rupture requiring treatment, NHLBI type C or higher dissection, thrombosis requiring revascularization, and no-reflow.
MACE Rate
MACE is defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization.
Patient-oriented Composite Endpoint (PoCE) Rate
PoCE is defined as all-cause death, stroke, all myocardial infarction, and any revascularization.
Target Lesion Failure (TLF) Rate
TLF is defined as cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization.
Target Vessel Failure (TVF) Rate
TVF is defined as cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.
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