NCT04298307已完成不适用
Prospective, Multicenter, Observational, Single-arm Registry of Coronary Lithotripsy for the Management of Calcified Lesions in Spain.
Fundación EPIC26 个研究点 分布在 1 个国家目标入组 426 人开始时间: 2020年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 26
- 主要终点
- Procedural success
研究概览
简要总结
The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.
详细描述
The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.
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
- •Patients ≥ 18 years of age.
- •Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an ICL with the Shockwave catheter.
- •The patients have been informed of the study characteristics and have given their written informed consent.
排除标准
- •Refusal to participate in this study.
- •Patients whose life expectancy is < 1 year.
- •Patients with hemodynamic instability with Killip class III or IV.
结局指标
主要结局
Procedural success
时间窗: Index Procedure
Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis \< 20% without in-hospital complications ).
次要结局
- Death (all cause)(12 months)
- Death (cardiovascular)(12 months)
- Non-fatal Myocardial Infarction(12 months)
- Target Vessel Revascularization(12 months)
- Stent thrombosis of target lesion(12 months)
- MACE(12 months)
- Residual stenosis(Index Procedure)
研究者
研究点 (26)
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