Coronary Artery Stenosis
Conditions
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 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.
Interventions
DEVICECoronary Laser Atherectomy System
The investigational Coronary Laser Atherectomy System consists of two components: (1) a Coronary Laser Console, and (2) Single-use Laser Optical Fiber Catheters.
DEVICECVX300 Laser System
The control device is the Philips CVX300 Excimer Laser Ablation System, used with single-use ELCA (Excimer Laser Ablation) Catheters.
Sponsors
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 \<70% with evidence of ischemia. Evidence of ischemia includes any of the following: * Positive exercise stress test * FFR or QFR ≤0.8 * Meets severe stenosis criteria by intracoronary imaging (IVUS or OCT): MLA \<2.4 mm² for vessels with diameter \<3.0 mm; MLA \<2.7 mm² for vessels with diameter 3.0-3.5 mm; MLA \<3.6 mm² for vessels with diameter \>3.5 mm 3. Target lesion is a small-diameter predilation balloon (balloon diameter ≤1.5 mm), uncrossable and/or undilatable lesion (undilatable under stent post-dilation balloon rated burst pressure and/or special circumstances unsuitable for dilation), including calcified lesions, CTO lesions, in-stent restenosis, stent underexpansion, and high thrombus burden lesions. 4. Guidewire successfully passes through the true lumen of the target lesion without NHLBI type C or higher dissection.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | Up to 7 days post-procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Rate | Baseline procedure | 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 | Baseline procedure | Procedural success is defined as device success in the absence of procedure-related complications. |
| Procedure-related Complication Rate | Baseline procedure through 7 days post-procedure | 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. |
Contacts
CONTACTTingting Wu
Outcome results
None listed