Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.
Design: Prospective, multicenter, single-arm study with an extended follow-up period.
Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial).
Endpoints:
Primary: Surgical success rate (residual stenosis \<30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.
Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.
Inclusion criteria:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.
Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.
None
None
All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Cohort
Prospective
Not listed
Target lesion re-narrowing rate
Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.
Target lesion revascularization rate
Incidence of repeat revascularization procedures at the treated lesion, evaluated at 3 and 6 months.
MAE (Major Adverse Events) rate
Rate of major adverse events (death, myocardial infarction, stroke) within 3 and 6 months.
Ipsilateral stroke rate
Incidence of stroke on the treated side, confirmed by clinical and imaging studies at 3 and 6 months.
MACCE (Major Adverse Cardio-Cerebrovascular Events) rate
Composite rate of death, stroke, myocardial infarction, and revascularization at 3 and 6 months.
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