* Clinical Trial Summary * Trial Title:\*\* CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions * Sponsor:\*\* Shanghai Bluesail Boyuan Medical Technology Co., Ltd. * Clinical Trial Leader:\*\* Beijing Anzhen Hospital * Coordinating Investigator:\*\* Prof. Huo Xiaochuan * Study Purpose This trial assesses a new device-a single-use neurovascular intravascular shockwave catheter and therapy device-for treating calcified blockages in the carotid artery. It uses sound waves to break up calcium deposits, facilitating stent placement and blood flow restoration. * Eligibility * Adults aged 18-80 with severe carotid artery narrowing (≥50% symptomatic or ≥70% asymptomatic) due to calcium buildup. * Patients who failed standard balloon dilation. * Exclusions include pregnancy, recent strokes/heart attacks, uncontrolled hypertension, or other high-risk conditions. * Study Design * \*\*Type:\*\* Prospective, multicenter, single-arm trial. * \*\*Sample Size:\*\* 204 patients across multiple hospitals. * \*\*Duration:\*\* 1-month follow-up post-procedure. * Procedures 1. \*\*Pre-treatment:\*\* Imaging (CT angiography, ultrasound) to confirm eligibility. 2. \*\*Procedure:\*\* Shockwave catheter breaks up calcium, followed by stent placement. 3. \*\*Follow-up:\*\* Assessments at 7 days (or discharge) and 1 month post-procedure. * Benefits and Risks * \*\*Benefits:\*\* Improved stent placement success, reduced risk of complications, minimally invasive with shorter recovery time. * \*\*Risks:\*\* Bleeding, infection, vessel damage, stroke, heart attack, device malfunction. Risks are closely monitored with emergency protocols. * Patient Protections * Ethics committee approval and strict safety guidelines. * Voluntary participation with the option to withdraw anytime. * Free treatment and compensation for trial-related injuries. * For Healthcare Providers * \*\*Innovation:\*\* Adapts coronary lithotripsy technology for carotid use. * \*\*Evidence:\*\* Supported by preclinical data and a pilot study (100% success rate in 5 patients). * \*\*Endpoints:\*\* Primary: Stent success (residual stenosis \<30%) and 30-day major adverse events. Secondary: Device success rate, repeat procedures, long-term outcomes. * Contact Information For questions, contact: \*\*Ms. Zhang Yanjiao\*\* Email: yanjiao.zhang@jwmsgrp.com
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Procedural Success Rate
Timeframe: Immediately post-procedure (intraoperative).
30-Day Major Adverse Events (MAE) Rate
Timeframe: 30 days (±7 days) post-procedure.