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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
The investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.
The 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).
Time frame: 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.
Time frame: Baseline procedure
Procedural Success Rate
Procedural success is defined as device success in the absence of procedure-related complications.
Time frame: Baseline procedure
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.
Time frame: Baseline procedure through 7 days post-procedure
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