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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Target lesion re-narrowing rate
研究概览
简要总结
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.
详细描述
Detailed Description
This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. The study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）.
Study Population:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.（The registered clinical trial:Participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by CT angiography (CTA) and digital subtraction angiography (DSA) are eligible. Patients who have failed conventional balloon dilation and are planned for carotid artery stenting (CAS) will be included.）
Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Assessments will include clinical evaluations, imaging studies (CT angiography or carotid ultrasound), and recording of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Target lesion re-narrowing rate
时间窗: at 3 months and 6 months postoperatively
Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.
次要结局
- Ipsilateral stroke rate(at 3 months and 6 months postoperatively)
- Target lesion revascularization rate(at 3 months and 6 months postoperatively)
- MAE (Major Adverse Events) rate(at 3 months and 6 months postoperatively)
- MACCE (Major Adverse Cardio-Cerebrovascular Events) rate(at 3 months and 6 months postoperatively)