Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)

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.

NCT Number	NCT06936189
Lead Sponsor	Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Conditions	Carotid Artery Stenosis
Enrollment	204 participants
Start Date	2025-05-12
Primary Completion	2027-12-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-16