The Use of Very Long Versus Overlapping Drug Eluting Stents for the Management of Long Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months
研究概览
简要总结
This study is performed to compare the angiographic and clinical outcomes of the use of single long stent versus overlapping stents in the treatment of long coronary lesions in patients with chronic coronary syndrome.
详细描述
Percutaneous coronary intervention (PCI) in diffuse coronary artery disease is still considered a big obstacle for interventional cardiologists. Very long coronary lesions are usually found, and implantation of a single stent was a great problem forcing the operator to do overlapping of several stents.
Recently, new stent designs with increasing length are developed and emerging as a great tool for the percutaneous treatment of long lesions. Nowadays, stents up to 60 mm are available to be used in these cases reducing stent overlap.
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention has been shown in clinical trials, registries, and meta-analyses to be associated with a reduction in clinical events after percutaneous coronary intervention; however, IVUS utilization during percutaneous coronary intervention remains low in the United States and worldwide. The impact of IVUS in these complex lesions may be associated with a lower rate of clinical adverse events in comparison with angiography alone.
The study will be conducted on forty patients with chronic stable angina on maximal medical treatment who are going to have elective coronary angiography and elective PCI and having one long coronary lesion that is more than 40 mm in length, they will be randomized into either treatment of the lesion with a single very long stent (more than 40 mm in length) or with more than one overlapping stents in 1:1 randomization. Control angiography and IVUS will be done to the 2 groups after 6 months and the major cardiovascular outcomes will be addressed at 1,3 and 6 months follow-up periods.
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
- •Patients > 18 years of age
- •Single vessel disease and undergoing PCI for significant long lesion.
- •Chronic stable angina on maximal medical treatment.
排除标准
- •Patients presenting with acute coronary syndromes.
- •Patients having two or more vessel disease on coronary angiography.
- •Previous myocardial infarction.
- •Previous vascularization either by PCI or bypass grafting.
- •Very low ejection fraction less than 35%.
- •Renally impaired patients with Creatinine clearance less than 50 ml/min.
- •Contraindication to dual antiplatelet drug therapy.
- •Contraindication to coronary angiography.
结局指标
主要结局
Major Cardiovascular and Cerebrovascular Events (MACCE) after 6 months
时间窗: 6 months
Number of patients with any Major Cardiovascular and Cerebrovascular Events (MACCE) at 6 months of stent deployment
Coronary angiographic criteria after 6 months of stent deployment
时间窗: 6 months
Number of participants with any form in-stent restenosis using control coronary angiography at 6 months
(IVUS) after 6 months of stent deployment
时间窗: 6 months
Number of participants with any form in-stent restenosis using Intravascular Ultrasonography (IVUS) at 6 months to assess subclinical neointimal proliferation and in-stent restenosis
次要结局
- Any Major Bleeding Event(6 months)