Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Evaluating a new treatment for calcified carotid artery stenosis

Official title: A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)) (Extended Follow-Up)

Run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. · NCT06936189 · Data updated 2026-11-12

This study is testing a new treatment for people with narrowed carotid arteries due to calcium buildup to see if it helps improve their condition safely over time.

More Carotid Artery Stenosis trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment204 (estimated)
SponsorShanghai Bluesail Boyuan Medical Technology Co., Ltd.
Industry-sponsored
Locations1 site (Beijing)
StatusRecruiting
StartedMay 12, 2025
Main results expectedDecember 30, 2027
Study endsDecember 30, 2027
Registry record updatedMay 16, 2025
Trial IDNCT06936189 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 18-80 with symptomatic or asymptomatic calcified carotid artery stenosis confirmed by imaging studies.

Probably not a fit

Patients who do not have calcified carotid artery stenosis or those who have contraindications for carotid artery stenting may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the long-term safety and efficacy of an intravascular lithotripsy system designed for pre-treatment of calcified carotid artery stenosis. It is a prospective, multicenter, single-arm study involving 204 participants who have symptomatic or asymptomatic carotid artery stenosis. Participants will be followed up at 3 and 6 months postoperatively to evaluate surgical success and other secondary endpoints related to re-narrowing and adverse events. The study aims to provide insights into the effectiveness of this novel treatment approach.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and reduce complications for patients with calcified carotid artery stenosis.

How similar studies have gone: While this approach is relatively novel, similar studies have shown promise in treating calcified lesions in other vascular territories.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

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

Exclusion criteria:

none

Where it's running

  • Beijing Anzhen Hospital
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.