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

NCT06936189 | Recruiting

• 1 other identifier: LFBY-202502
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion re-narrowing rate

  Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.

  at 3 months and 6 months postoperatively

Secondary Outcomes (4)

• Target lesion revascularization rate

  at 3 months and 6 months postoperatively

• MAE (Major Adverse Events) rate

  at 3 months and 6 months postoperatively

• Ipsilateral stroke rate

  at 3 months and 6 months postoperatively

• MACCE (Major Adverse Cardio-Cerebrovascular Events) rate

  at 3 months and 6 months postoperatively

Study Arms (1)

Calcified Carotid Artery Stenosis Treated with IVL and Carotid Artery Stenting (CAS)

All patients participating in this extended follow-up period are sourced from the registered clinical trial.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients participating in this extended follow-up period are sourced from the registered clinical trial.

You may qualify if:

• All patients participating in this extended follow-up period are sourced from the registered clinical trial.

You may not qualify if:

• none

Sponsors & Collaborators

• Shanghai Bluesail Boyuan Medical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaochuan Huo

CONTACT

010-64412431; huoxiaochuan@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)