Calcification Remodeling Utilizing Shockwave LiThotripsy in Coronary Artery CaLcification (Guangxi Real-World Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Procedure success
研究概览
简要总结
This is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using Shockwave IVL catheter in the treatment of coronary artery calcification in real-world clinical practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians.
- •The subject or their legal representative agrees to sign the informed consent form.
排除标准
- •The physician evaluates that the subject's expected lifespan is <1 year.
- •The subject did not receive IVL treatment in the index procedure.
- •The subject is pregnant or lactating.
- •The subject is currently participating in another clinical study.
结局指标
主要结局
Procedure success
时间窗: in 48 hours post-procedure or prior to discharge, whichever comes first
Procedure success defined as successful stent implantation, residual stenosis degree \<30% (core laboratory), and no major adverse cardiac events (MACE) occurring during hospitalization
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure
时间窗: 30 days post index procedure
MACE is defined as: Cardiac death; or Myocardial Infarction (MI): Follow the Fourth Universal Definition of Myocardial Infarction ; or Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure; or Target lesion thrombosis.
次要结局
- Vascular complications in the proudure(Immediately post index procedure)
- Incidence of target lesion revascularization(12 months post index procedure)
- 30 days post index procedure(9 months post index procedure)