Status:
RECRUITING
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)
Lead Sponsor:
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-80 years
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...
Detailed Description
\### Detailed Description This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatmen...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All patients participating in this extended follow-up period are sourced from the registered clinical trial.
- Exclusion criteria:
- none
Exclusion
Key Trial Info
Start Date :
May 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06936189
Start Date
May 12 2025
End Date
December 30 2027
Last Update
May 16 2025
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, China