A Prospective Multicenter Indian LMCA Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,500
- 试验地点
- 49
- 主要终点
- 1. Procedural success
研究概览
简要总结
The left main coronary artery is distinguished by its larger diameter, broad distal bifurcation angle and the perfusion of a significant portion of the myocardium. The disease of LMCA are associated with the highest risk of morbidity and mortality among the subsets of coronary artery diseases with 70% damage to the myocardium when compared with other obstructive CADs.
Coronary artery bypass grafting (CABG) has traditionally been the gold standard for the management of patients with LMCA. However, percutaneous coronary intervention (PCI) has emerged as an alternative to CABG owing to its low periprocedural risk and continuous advancement in technology to provide better long-term outcomes and prognosis. Various systematic reviews and meta-analyses have documented clinical outcomes and long-term mortality among patients undergoing LMCA revascularization with CABG and PCI techniques. The drug-eluting stents have been a breakthrough in the PCI of LMCA and literature provides evidence on the safety and efficacy of using these stents in LMCA stenosis
There is a dearth of research on the clinical outcome of PCI for treating lesions in LMCA in India. Considering this, the data for the registry will be collected to assess the clinical outcomes of PCI with DES in patients with lesions in LMCA. This registry will be a prospective, multicentre, observational data collection study involving patients requiring PCI in LMCA.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of either gender aged ≥18years, with a diagnosis of stable ischemic heart disease (SIHD) or acute coronary syndrome (ACS)
- •PCI with single or multiple DES for the treatment of lesion located at LMCA and defined as diameter stenosis ≥50% by visual estimation
- •Patients willing to sign the informed consent form.
排除标准
- •Patients who have a life expectancy of less than 12 months
- •Contraindication for dual antiplatelet therapy(DAPT).
结局指标
主要结局
1. Procedural success
时间窗: 1. In-hospital | 2. 12 Months
2. Rate of MACE
时间窗: 1. In-hospital | 2. 12 Months
次要结局
- Rate of individual MACE - cardiac death, MI, TLR, TVR(12 Months)
研究者
Dr Prathap Kumar N
Interventional Cardiology Research and Training Foundation
