Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- To evaluate the safety and performance of the Shockwave Medical® C2 Coronary Lithotripsy System (IVL), Inc. in coronary angioplasty in "all patients" in France.
研究概览
简要总结
Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes. Moreover, calcified lesions are underestimated in angiography and associated with an increase in angiographic complications, as well as with a worse clinical prognosis. The usual techniques for the preparation of calcified plaque, in particular rotary atherectomy, have a low penetration rate in France (3% of procedures) and are associated with an increase in per-procedural complications without clinical evidence of effectiveness4. A new device has been developed by Schockwave Medical Inc. for the treatment of calcified lesions to facilitate stent delivery: the C2 Shockwave Medical® Coronary Lithotripsy System (IVL), Inc. This system uses the principle of lithotripsy to induce microfractures in the calcified plaque prior to low-pressure balloon dilatation. The objective of the study is to evaluate the safety and performance of the C2 Shockwave Medical® (IVL), Inc. coronary lithotripsy system in coronary angioplasty in the general population in France.
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
- •Patient over 18 years old
- •Patient affiliated to the National Health Insurance System
- •Patient for whom a coronary angioplasty procedure is performed using the Shockwave Medical C2 Coronary Lithotripsy System
- •For indications of stent malexpansions, stent malexpansion must be defined by: a) angiography: stent malexpansion >30% (QCA and/or stent magnification) b) endocoronary OCT/IVUS imaging with MSA (Minimal Stent Area) <4.5 mm2 or a ratio of MSA/MLA on reference segment<0.8
- •Patient willing to participate in the registry
排除标准
- •Patient under 18 years of age
- •Pregnant or breastfeeding patient
- •Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or legal guardianship)
结局指标
主要结局
To evaluate the safety and performance of the Shockwave Medical® C2 Coronary Lithotripsy System (IVL), Inc. in coronary angioplasty in "all patients" in France.
时间窗: 1 year after procedure
Target Vessel Failure (TVF) composite endpoint at 1 year: * Cardiac death * Myocardial infarction according to ARC II definition of myocardial infarction (unless the infarction is clearly attributable to a non-target vessel) * Target vessel revascularization (TVR)
次要结局
- To evaluate the procedural success in de novo lesions(During initial hospitalization, within 2-4 days after procedure)
- To evaluate the procedural success in stent malexpansion(During initial hospitalization, within 2-4 days after procedure)
- To evaluate the rate of MACE during the year of follow-up(1 year after procedure)
- To evaluate the rate of stent thrombosis during the year of follow-up(1 year after procedure)
- To evaluate the rate of per-procedural coronary complications(During initial hospitalization, within 2-4 days after procedure)
- To evaluate the device success(During initial hospitalization, within 2-4 days after procedure)
- To evaluate the rate of target lesion failure during the year of follow-up(1 year after procedure)