LUDICO Study: Effectiveness and Safety of Coronary Laser in UnDIlatable or unCrOssable Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Laser Success
研究概览
简要总结
This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation <80% at burst pressure) or uncrossable (not crossable with a "small-profile balloon" with adequate support, according to operator´s discretion) coronary lesions treated with ELCA will be included. Intravascular imaging will be highly recommendable and analysed in a central core-laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be followed for 1 year after the procedure and clinical events will be recorded.
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 aged over 18 years.
- •Patients with either stable coronary artery disease or acute coronary syndromes as the clinical presentation.
- •Patients with severe coronary lesions (>70% by visual estimation) in native vessels or coronary bypass grafts.
- •"Uncrossable" coronary lesions (i.e., lesions that cannot be crossed with a 0.7:1 balloon after successful guidewire passage) or "Undilatable" lesions (i.e., those in which balloon dilation with a 1:1 non-compliant balloon at 18 atm results in less than 80% expansion relative to the distal reference vessel diameter; this group includes both de novo lesions and in-stent restenosis or underexpanded stents).
排除标准
- •Patients with known allergies to aspirin (ASA), clopidogrel, prasugrel, or ticagrelor.
- •Patients unable to provide informed consent, either personally or through a legal representative.
- •Patients with clinical or hemodynamic instability defined as: sustained hypotension (systolic blood pressure ≤ 90 mmHg for ≥ 30 minutes or use of pharmacological and/or mechanical support to maintain an SBP ≥90 mmHg) or evidence of end-organ hypoperfusion including urine output of <30 mL/h, cool extremities, altered mental status, and/or serum lactate >2.0 mmol/L.
- •Patients with significant comorbidities and a life expectancy of less than one year.
结局指标
主要结局
Laser Success
时间窗: From enrollment to the end of the procedure at 4 hours.
For uncrossable lesions, it will be defined as the ability of the laser catheter to cross the lesion. Laser success will be also considered in cases in which the laser catheter cannot cross the lesion but its application proximal to it allows subsequent crossing of balloons. For undilatable lesions, laser success will be defined as successful balloon dilation (sized 1:1 to the vessel diameter), with adequate expansion (\>80% in two orthogonal projections) following laser therapy without the need of other plaque modification technique.
次要结局
- Angiographic success(From enrollment to the end of the procedure at 4 hours.)
- Procedural success(From enrollment to the end of the procedure at 4 hours.)
- Intracoronary imaging-based success(From enrollment to the end of the procedure at 4 hours.)
- Events at 1 year(From enrollment to 1 year after the procedure)
研究者
Alfonso Jurado, MD, PhD
Principal investigator
Hospital Universitario La Paz