NCT06936189 Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)
| NCT ID | NCT06936189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Bluesail Boyuan Medical Technology Co., Ltd. |
| Condition | Carotid Artery Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 204 participants in total. It began in 2025-05-12 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria: All patients participating in this extended follow-up period are sourced from the registered clinical trial. Exclusion criteria: none
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06936189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Carotid Artery Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936189 currently recruiting?
Yes, NCT06936189 is actively recruiting participants. Contact the research team at huoxiaochuan@126.com for enrollment information.
Where is the NCT06936189 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06936189 clinical trial?
NCT06936189 is sponsored by Shanghai Bluesail Boyuan Medical Technology Co., Ltd.. The trial plans to enroll 204 participants.