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.
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