Evaluating a new treatment for calcified carotid artery stenosis
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)
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Bluesail Boyuan Medical Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06936189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-80 with symptomatic or asymptomatic calcified carotid artery stenosis confirmed by imaging studies.
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.
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 performed: While this approach is relatively novel, similar studies have shown promise in treating calcified lesions in other vascular territories.
Eligibility criteria
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 this trial is running
Beijing
- Beijing Anzhen Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaochuan Huo
- Email: huoxiaochuan@126.com
- Phone: 010-64412431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.