"IVUS-Trained Eye" vs. Intravascular Ultrasound in Left Main Bifurcation Stenting: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relative optimal LM stent expansion
研究概览
简要总结
This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability. The primary objective is to compare the planimetric stent appearance between two strategies.
详细描述
Stenting of the left main coronary artery in bifurcation lesions remains one of the most technically demanding tasks in interventional cardiology. Stent implantation quality is directly linked to the risk of adverse outcomes. Minimal stent area (MSA), as measured by IVUS, is a key predictor of adverse clinical outcomes. In practice, however, many centers continue to rely on angiographic assessment alone when performing various left main bifurcation stenting techniques. Proponents of this approach cite extensive clinical experience, anatomical familiarity, and IVUS-informed intuition developed over time (a "trained eye"). To date, no randomized data exist comparing outcomes of left main stenting between an IVUS-guided approach and a visually/experience-guided approach. Investigators hypothesize that, when combined with mandatory bifurcation optimization steps (e.g., proximal optimization technique [POT], kissing balloon inflation [KBI]), an angiography-only approach performed by an IVUS-experienced physician is non-inferior to a standard IVUS-guided approach, as assessed by post-PCI IVUS stent planimetric characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent)
- •Patient referred for elective or delayed (non-emergency) stenting
- •Technical feasibility of performing IVUS
- •Signed informed consent
排除标准
- •ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
- •Cardiogenic shock
- •Isolated (non-bifurcation) left main lesion
- •Prior PCI in the target segment
- •Diameter of one of the left main main branches < 2 mm
- •Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization
- •History of coronary artery bypass grafting (CABG)
- •Severe comorbidity with expected life expectancy < 1 year
- •Participation in another interventional study
- •Patient is a woman who is pregnant or nursing;
- •Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
- •IVUS is strictly required for pre-PCI lesion severity assessment
- •Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
- •Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
结局指标
主要结局
Relative optimal LM stent expansion
时间窗: Immediately post-procedure
Proportion of patients (%) achieving MSA ≥ 90% of the distal reference segment area according to IVUS, assessed after completion of all stenting and optimization steps
Absolute optimal LM stent expansion
时间窗: Immediately post-procedure
Proportion of patients (%) achieving MSA ≥ 11.4 mm² in the left main coronary artery according to IVUS, assessed after completion of all stenting and optimization steps
Device-oriented Composite Endpoint (DoCE)
时间窗: 1 year follow-up
Proportion of patients (%), achieving the device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel MI, clinically indicated repeat revascularization of the target lesion at longest follow-up
次要结局
- All individual components of DoCE at all time points.(1 year follow-up)
研究者
Conrady Alexandra
Deputy Director for Science
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
