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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Target lesion re-narrowing rate — at 3 months and 6 months postoperatively
  Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.

Trial sites (1)