Coronary Laser Atherectomy Registry From an International Taskforce
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ceric Sàrl
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Procedural success during index PCI
研究概览
简要总结
This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI).
详细描述
The primary objective of the CLARIT study is to assess the Safety and Efficacy of ELCA in recognized indications for the device at Index PCI and during the in-hospital stay. The secondary objectives includes the safety and efficacy of ELCA at 30 days and 1 year, as well as the procedural characteristics for the assessment of the learning curve and impact on the catheter lab workflow.
500 patients will be included in 20 sites accorss 8 countries in Europe, United Kingdom and India. The patients included in the study according to eligibility criteria will be followed up one year. The total study duration is 3 years, including 2 years of recruitment.
The follow-up/visit windows include the screening/baseline period, on the day of procedure, discharge; 1 month and 1 year follow-up. The ELCA is to be used following Instruction for uses and follow-up as per hospital standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects will be included if all the following criteria are met:
- •Age 18 years or over
- •Patient willing to be included in the registry
- •Patients with stable coronary artery disease or acute coronary syndromes with de-novo or intra-stent restenosis (ISR) coronary lesions suitable to be treated with ELCA
- •Non-Crossable with ICI catheter or:
- •Crossable with ICI catheter with significant calcium score suggesting need for calcium modification based on IVUS or OCT criteria and/or
- •Non-Dilatable with 1:1 NC balloon
- •Mandated use of ICI:
- •Attempted before use of ELCA or
- •Following ELCA and any other calcium modification strategy utilized (to evaluate whether the additional modification demonstrates significant additional modification of the calcium on ICI)
- •Final after DES implantation or prior to use of DCB
- •Declared PCI strategy (planned use of ELCA, need for IVL/specialty balloons/alternative atherectomy and stent strategy) prior to PCI procedure
排除标准
- •Pregnant or breast feeding
- •Unable to give informed consent
- •PCI performed without IVCI attempt
- •No ELCA use
- •Allergy to clopidogrel, prasugrel or ticagrelor or non-compliance
- •Post- cardiac arrest or haemodynamic instability
- •Participation in another trial.
结局指标
主要结局
Procedural success during index PCI
时间窗: During Procedure
The primary endpoint of efficacy is procedural Success during index PCI:, which is a combined endpoint of these following events: * Angiographic success defined as residual stenosis \<30% in two orthogonal projections after lesion treatment with ELCA destination therapy with DES or DCB * TIMI 3 flow and absence of ELCA related complications during the procedure * Intra-Coronary Imaging success defined as final MSA \> 5.5mm2 IVUS or 4.5mm2 OCT with \> 80% stent expansion - site reported
Freedom from in hospital Major Adverse Cardiovascular Events
时间窗: Periprocedural
The primary endpoint of safety is freedom from in-hospital Major Adverse Cardiovascular Events (MACE), including : cardiac death, target vessel myocardial infarction (TVMI), urgent repeat target vessel revascularization (TVR) with either PCI or CABG, and Stroke.
次要结局
- Composite endpoint of one of events reported(30 days and 1 year)
- Success of revascularization: Freedom from Target lesion failure (TLF) events and ICI assessed stent optimization(30 days and 1 year)
- Procedural Characteristic- Cost(During procedure)
- Procedural Characteristic- Device success based on maximum fluence(During procedure)
- Procedural Characteristic- Fluoroscopy Time(During procedure)
- Procedural Characteristic- Contrast Volume(During procedure)
- Procedural characteristic- Device success based on repetition rate(During procedure)
- Procedural characteristic- Device success based on pulses number(During procedure)
- Procedural characteristic- Device success based on lasing duration(During Procedure)
- Procedural characteristic- Device success based on laser trains number(During procedure)
- Procedural characteristic- Catheter access(During Procedure)
- Requirement of hemodynamic support(During procedure)
- Marker of the learning curve associated with ELCA- Total procedure time(During procedure)
- Marker of the learning curve associated with ELCA- Intra-procedural interval from ELCA decision to post-ELCA intracoronary imaging(During procedure)
- Marker of the learning curve associated with ELCA- Number of ECLA trains(During procedure)
- Marker of the learning curve associated with ELCA- Milieu type used during lasing(During procedure)
- Impact on catheter lab workflow- Lesion preparation strategy(During procedure)
- Impact on catheter lab workflow- Stent Strategy(During procedure)
- Impact on catheter lab workflow- Procedural duration(During procedure)
- Intracoronary imaging analysis by the site- Calcium morphology(During procedure)
- Intracoronary imaging analysis by the site- Depth of lesion calcification(During procedure)
- Intracoronary imaging analysis by the site- Lesion calcification length(During procedure)
- Intracoronary imaging analysis by the CoreLab(During procedure)
- Intracoronary imaging analysis by the CoreLab(During Procedure)
- Intracoronary imaging analysis by the CoreLab(during procedure)