Immediate and Midterm Clinical Outcome of Drug Coated Balloon Angioplasty in Different Coronary Artery Lesions in Sohag Governorate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events at 6 months
研究概览
简要总结
This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions
详细描述
The treatment of coronary lesions triggers processes in vessel walls with different characteristics depending on the revascularization strategy, post-traumatic healing following plain balloon angioplasty triggers vessel recoil and neointimal overgrowth, bare metal or drug eluting stent implantation results in neointimal cell proliferation, scar tissue formation, and ultimately, the generation of neoatherosclerosis Drug-coated balloons(DCBs) were presented two decades ago as an alternative to plain-balloon inflation or subsequent stent implantation in order to overcome in-stent restenosis.Recently, there has been growing evidence that DCBs can also be used off-label to treat de novo lesions in small vessels Therefore, the aim of this study is to evaluate efficacy and safety of drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.
排除标准
- •Severe renal impairment ( Cr.Cl. < 45 ml/min ).
- •Sever heart failure or liver cell failure .
- •Patients with contraindications to coronary angiography or invasive procedures.
- •Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- •Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
- •Pregnant or lactating women.
研究组 & 干预措施
Control
干预措施: Angioplasty (Device)
结局指标
主要结局
Major adverse cardiac events at 6 months
时间窗: 6 months
Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding \[BARC type 3 to 5\]) at 6 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
次要结局
未报告次要终点
研究者
Imran Saber Mohamed
Assistant lecturer
Sohag University