CAlcified Coronary Lesions Identification & Quantification With X Rays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°).
研究概览
简要总结
The CALIQX trial is a prospective, multicenter, non-randomized pilot study comparing the 3DStent and IVUS methods for quantifying native coronary calcifications. The trial falls under classification 4.3 according to the classification and evaluation process under EU Regulation 2017/745 (MDR) and national adaptation of clinical investigations concerning medical devices: CE-marked medical device (any class), used off-label without the objective of CE marking or establishing conformity.
Compare the evaluation of native coronary calcifications with 3D Stent tool versus evaluation by intracoronary IVUS imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male or female aged 18 years or older
- •Patient with a coronary lesion.
- •Angiographically calcified culprit lesion (Mintz classification) 1 Moderate: lesion with radiopaqueness noted only during the cardiac cycle before contrast injection Severe: lesion with radiopaqueness seen without cardiac motion before contrast injection, visible on both sides of the arterial lumen
- •Ability to traverse the culprit lesion with an IVUS catheter
- •Having been informed by an investigator about the research topic and having given their free, explicit, and informed consent.
- •Affiliation with a social security scheme (beneficiary or dependent)
排除标准
- •Acute coronary syndrome of the ST-segment elevation myocardial infarction type
- •Progressive cardiogenic shock
- •Culprit lesion impassable with an IV catheter
- •Pregnant, parturient, or breastfeeding women and other vulnerable categories: legally incapacitated adults, adults unable to express their consent and not subject to a protective measure, persons deprived of their liberty
- •BMI > 35 kg/m²
研究组 & 干预措施
IVUS and 3DStent
干预措施: Imaging by IVUS and 3D Stent (Device)
结局指标
主要结局
Radial extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in degrees (°).
时间窗: Day 1
To assess one of the components of the baseline calcium burden of the plaque by measuring its length by comparing 3DS measurement and IVUS measurement
次要结局
- Procedural radiation dose post procedural in milliGray (mGy)(Day 1)
- Longitudinal extent of calcification at baseline/ before stent implantation, measured by 3DStent (post-procedure) and IVUS, expressed in millimeters (mm)(Day 1)
- Maximum calcification thickness at baseline/ before stent implantation measured by 3DStent (post-procedure), expressed in micrometers (µm)(Day 1)
- Minimum intra-stent area post procedural , measured by 3DStent and IVUS, expressed in square millimeters (mm²).(Day 1)
- Procedural mean contrast volume in milliliters (ml)(Day 1)
- Procedure duration, expressed in minutes (mins)(Day 1)
- Adverse cardiovascular event (cardiovascular death + stent thrombosis + myocardial infarction + need for target vessel revascularization) at 30 days post-angioplasty in percent of the study population(Day 30)